Clinical Study to Measure the Impact of Fortified Malt Based Food on Immunity Outcomes in School Children
Phase: NA
Conditions: Growth and Development
Sponsor: GlaxoSmithKline

C o p y rig ht:  Gl a x o S mit h Kli ne.  A n u n p u blis he d w or k s u bject t o tra de secret 
pr otecti o n.  T hi s w or k c o ntai ns c o nfi de ntial a n d pr o prietar y inf or mat i on of 
Gl a x o S mit hKli ne a n d s h o ul d n ot be c o pi e d, circ ulate d, or distri b ute d t o pers o ns n ot 
e mpl o y e d b y Gla x o S mit hKli ne u nless s pecificall y a ut h orize d.  U na ut h orize d 
di s clos ure of t his w or k is e x pressl y  pr o hi bite d.
Cli nical Pr ot oc ol
2 0 4 4 7 7
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 of 1 2 2

C O N FI D E N TI A L
S U M M A R Y I N F O R M A TI O N
Title:
Cli nical st u d y  t o meas ure t he i m pact of 
f ortifie d malt base d f o o d o n i m m u nit y 
o utc o m es i n sc h o ol c hil dre n
Pr ot oc ol N u m ber:
2 0 4 4 7 7
S p o ns or:
Gl a x o S mit hKli ne C o ns u mer Healt hcare 
( G S K C H)
Pl ot N u m ber 6 7, Sect or 3 2, G ur ga o n, 
Har y a na, I n dia
P h -
Pr o d uct N a me:
F ortifie d malt base d f o o d
De vel o p me nt P h ase:
N A
E x pert A d vice O utsi de of N or m al 
W or ki n g H o u rs:
Dr 
, M D, G S K C H
T el : 
Ke y Pr ot oc ol A ut h ors:
P RI M A R Y C O N T A C T
Cli nic al St u d y M a n a ger:
, M Sc., G S K C H
Researc h & De vel o p me nt Ce ntre,
Pl ot n o. 6 7, Sect or – 3 2, G ur ga o n, 
1 2 2 0 0 1, Har y a na, I n dia
T el : 
Fa x:
Bi ost atistici a n:
, 
M Sc ., G S K C H
Me dic al Le a d:
Dr. 
, M D, G S K C H
Ot her Pr ot oc ol A ut h ors:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 of 1 2 2
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

Cli nic al S u p plies:
, G S K C H
D at a M a n a ger:
, M P har m, G S K C H
Me dic al/ De nt al
E x pert:
Dr 
, M B B S, M Sc., 
G S K C H
Pri nci p al I n vesti g at or:
Dr A n ura d ha K ha dil kar , M B B S, M D
St u d y Site N a me & A d dress:
Je ha n gir Cli nical De vel o p me nt Ce ntre,
Sass o o n R oa d, P u ne, Ma haras htra,
I n dia
St u d y  Sites:
1.
Ge n ba S o pa nra o M oze Pras hala 
( E n glis h & Marat hi Me di u m), 
1 9 1/ A Na g p ur C ha wl r oa d,
Ma hara s htra C o-o perati ve 
H o usi n g B oar d, Yera wa da, P u ne
4 1 1 0 0 6
D o n B osc o hi g h sc h o ol, S hastri 
Na gar c h o w k, near I B M, D o n 
B osc o r oa d , Yer wa da P u ne 
Ma haras htra 4 1 1 0 0 6
1.
D O N B O S C O HI G H S C H O O L
S H A S T RI N A G A R C H O W K, 
N E A R I B M, 
D O N B O S C O R O A D, 
Y E R W A D A, P U N E 4 1 1 0 0 6
2.
C hai ta n ya E n glis h Me di u m 
Sc h o ol , Area N o: 5 8 8, Rasta Pet h, 
P u ne Ma haras htra 4 1 1 0 1 1
Ut kars h E n glis h Me di u m Sc h o ol, 
Area N o: 2 7 8, ne xt t o c o m m u nit y 
hall, o p p osite Sai nt A n nes c h urc h, 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 of 1 2 2
P P D
P P D
P P D

S ol a p ur Bazar, Ca m p, P u ne 
4 1 1 0 0 1
D h o le Patil G o ver n me nt sc h o ol, 
D h o le Patil r o a d, P u ne-4 1 1 0 0 1
3.
S A N E G U R U JI M A R A T HI 
M E DI U M S C H O O L, 
M A H A R A S H T R A A R O G Y A 
M A N D A L, M A L W A DI 
H A D A P S A R, P U N E 4 1 1 0 2 8
4.
F A T H E R A G N E L' S 
VI D Y A N K U R E N G LI S H 
S C H O O L, V A D G A O N S H E RI, 
P U N E 4 1 1 0 2 6
B A C K -U P S C H O O L
S T F R A N CI S HI G H S C H O O L, 
2 5/ 2 N A R V E E R 
T A N A JI W A DI, 
S HI V A JI N A G A R P U N E 
4 1 1 0 0 5
1. P H O E NI X E N G LI S H M E DI U M 
S C H O O L , T U K A R A M N A G A R, 
C H A N D A N N A G A R, P U N E 
4 1 1 0 1 4
2. L A T E B A N D O JI K H A N D O JI 
C H A V A N S C H O O L
S U R V E Y N O 4 8
I N D R A P R A S T H N A G A R
S H O B H A P U R, D H A Y A RI 
P U N E, M A H A R A S H T R A 
4 1 1 0 4 1
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 of 1 2 2

St u d y Site Tele p h o ne N u m ber:
St u d y E x a mi ner(s ):
N A
Cli nic al & A n al ytic al L a b or at or y:
I nter Vei n La b orat ories Pri vate Li mit e d, 
S ha pat h I V,
B 5 0 1 - 5 0 2-5 0 3 S. G. Hi g h wa y,
A h m eda ba d 3 8 0 0 5 4, G ujarat, I n dia
C o ntr act Rese arc h Or g a nis ati o n
( C R O):
Cli n Tec I nter nat i onal Lt d.
# 3 8 0, 2 n d Fl o or I T TI N A Ce nter S er vice 
R oa d, K ora ma n gala 3r d Bl oc k , 
Ba n gal ore - 5 6 0 0 3 4 , I n dia
Re g ul at or y A ge nc y I de ntifier N u m ber 
(if a p plic a ble):
N A
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 of 1 2 2
P P D

P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T 
P A G E

I c o nfir m a gree me nt t o c o n d uct t he st u d y in c o m p lia nce with t he pr ot oc ol a n d 
a n y a me n d me nts a n d acc or di n g t o t he c urre nt I C H G C P g ui deli nes.

I ac k n o wle d ge t hat I a m res p o nsi ble f or o verall st u d y c o n d uct. I a gree t o 
pers o nall y c o n d uct or s u per vise t he descri be d st u d y.

I a gree t o e ns ure t hat all ass ociates, c ollea g ues a n d e m pl oyees assist i n g i n t he 
c o n d uct of t he st u d y are i nf or me d a b o ut t heir o bli gatio ns. Mec ha nis ms are i n 
pl ace t o e ns ure site staff recei ves all a p pr o priate i nf or mat i on t hr o u g h o ut t he 
st u d y.

I a gree t o c o n d uct t his st u d y in f ull c o nf or ma nce with t he l a ws a n d re g ulati o ns 
of  t he c o u ntr y in w hic h t he researc h is c o n d ucte d a n d t he Declarati o n of 
Helsi n ki.
I n vesti gat or Na me:
Dr A n ura d ha K ha dil kar
I n vesti gat or Q ualificati ons:
M B B S, M D
I n vesti gat or Si g nat ure:
Date of Si g nat ure/ A gree me nt:
D D/ M M M/ Y Y Y Y
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 of 1 2 2
P P D

T a ble of C o nte nt
S U M M A R Y I N F O R M A TI O N ...............................................2
P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T 
P A G E ..............................................................................6
T a ble of C o nte nt ......................................................................7
P R O C E S S F O R A M E N DI N G T H E P R O T O C O L ...............1 2
S C H E D U L E O F E V E N T S .....................................................2 5
P R O T O C O L S Y N O P SI S F O R S T U D Y 2 0 4 4 7 7 ...................2 6
1. I N T R O D U C TI O N ...............................................................3 3
2. O B J E C TI V E S A N D E N D P OI N T S ....................................3 6
3. S T U D Y P L A N .....................................................................3 8
3. 1. St u d y Desi g n ......................................................................3 8
3. 2. S u bject Restricti o ns ..........................................................4 0
3. 3. T y pe a n d Pl a n ne d N u m ber of P artici p a n ts .....................4 1
3. 4. St u d y Desi g n a n d D ose J ustific ati o n ................................4 1
4. S E L E C TI O N O F S T U D Y P O P U L A TI O N A N D 
WI T H D R A W A L C RI T E RI A ........................................4 6
4. 1. I ncl usi o n Criteri a ..............................................................4 7
4. 2. E xcl usi o n Criteri a .............................................................4 7
4. 3. Scree ni n g/ B aseli ne F ai l ures.............................................4 9
4. 4. Wit h dr a w al/ St o p pi n g Criteri a ........................................4 9
4. 5. S u bject Re pl ace me nt .........................................................5 0
4. 6. S u bject a n d St u d y C o m pleti o n .........................................5 0
5. P R O D U C T I N F O R M A TI O N .............................................5 0
5. 1. St u d y Pr o d uct ....................................................................5 0
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 of 1 2 2

5. 2. D ose Sc he d ule ....................................................................5 1
5. 3. D ose A d mi nistr ati o n .........................................................5 1
5. 4. D ose M o dific ati o n .............................................................5 1
5. 5. Pr o d uct C o m pli a nce .........................................................5 2
5. 6. Prec a uti o ns ........................................................................5 2
5. 7. O ver d ose ............................................................................5 2
5. 8. Resc ue T her a p y .................................................................5 2
5. 9. Pr o d uct Assi g n me nt ..........................................................5 3
5. 9. 1 R a n d o mis ati o n ...................................................................5 3
5. 9. 2 Bli n di n g ..............................................................................5 3
5. 9. 3 C o de Bre a ks .......................................................................5 3
5. 1 0. P ac k a gi n g a n d L a belli n g ................................................5 4
5. 1 0. 1. Acc o u nt a bilit y of Pr o d uct ..............................................5 4
5. 1 0. 2. St or a ge of Pr o d uct ..........................................................5 5
6. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ..............5 5
6. 1. M atc he d P air F or m ati o n ..................................................5 5
6. 2. I nf or me d C o nse nt a n d Asse nt ..........................................5 5
6. 3. De m o gr a p hics ....................................................................5 6
6. 4. Me dic al Hist or y a n d C o nc o mit a nt Me dic ati o n ...............5 7
6. 5. Ge ner al P h ysic al E x a mi n ati o n .........................................5 7
6. 6. Vit al Si g ns ..........................................................................5 7
6. 7. A nt hr o p o metric Me as ure me nts ( Hei g ht, Wei g ht, B MI a n d 
H A Z) ................................................................................5 8
6. 8. H b Assess me nt ...................................................................5 8
6. 9. C ollecti o n, St or a ge, Assess me nt a n d Destr ucti o n of H u m a n 
Bi ol o gic al S a m ples ..........................................................5 8
6. 9. 1. C ollecti o n a n d St or a ge of H u m a n Bi ol o gic al S a m ples ...5 9
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 of 1 2 2

6. 9. 2. L a b or at or y Assess me nt a n d Destr ucti o n of H u m a n 
Bi ol o gic al S a m ples ...........................................................6 2
6. 1 0. Diet ar y C o u nselli n g .........................................................6 2
6. 1 1. Cli nic al O utc o mes Assess me nt .......................................6 3
6. 1 1. 1. C ase/Ill ness defi niti o n ....................................................6 3
6. 1 1. 2. M or bi dit y O utc o mes Defi niti o ns ...................................6 4
6. 1 1. 3. Cli nic al E v al u ati o n T o ols ...............................................6 5
6. 1 2. St u d y P h ysici a n Wee kl y Re vie w ....................................6 6
6. 1 2. 1. C ollecti o n of S y m pt o m C hec klist ..................................6 7
6. 1 2. 2.
St u d y P h ysici a n Cli nic al Hist or y a n d E x a mi n ati o n . 6 7
6. 1 3. 2 4 hr Diet ar y Rec all & Diet ar y Di versit y S ur ve y ..........6 8
6. 1 3. 1. 2 4 hr Diet ar y Rec all .......................................................6 8
6. 1 3. 2. Diet ar y Di versit y S ur ve y ................................................6 9
6. 1 3. St u d y C o ncl usi o n .............................................................7 0
7. S A F E T Y A S S E S S M E N T S ..................................................7 1
7. 1. Defi niti o ns of a n A d verse E ve nt a n d Seri o us A d verse 
E ve nt ................................................................................7 1
7. 1. 1. A d verse E ve nts ................................................................. 7 1
7. 1. 2. Seri o us A d verse E ve nts ....................................................7 2
7. 2. Rec or di n g A d verse E ve nts a n d Seri o us A d verse E ve nts 7 3
7. 3. E v al u ati n g A d verse E ve nts a n d Seri o us A d verse E ve nts 7 4
7. 4. Re p orti n g A d verse E ve nts a n d Seri o us A d verse E ve nts .7 6
7. 5. F oll o w -u p of A d verse E ve nts a n d Seri o us A d verse E ve nts
.........................................................................................7 7
8. D A T A M A N A G E M E N T ....................................................7 9
8. 1. S o urce D oc u me nts/ D at a ...................................................7 9
8. 2. Electr o nic C ase Re p ort F or m ...........................................7 9
8. 3. D at a H a n dli n g ...................................................................8 0
8. 3. 1. D at a Q ueries .....................................................................8 0
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 of 1 2 2

8. 4. Pr ocessi n g P atie nt Re p orte d O utc o mes ...........................8 1
8. 5. E xter n al D at a ....................................................................8 1
9. S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A 
A N A L Y S E S ....................................................................8 1
9. 1 S a m ple Size Deter mi n ati o n ................................................8 1
9. 2. Ge ner al C o nsi der ati o ns ....................................................8 3
9. 2. 1. Defi niti o n of A n al ysis P o p ul ati o ns ..................................8 3
9. 2. 2. E xcl usi o n of D at a fr o m A n al ysis .....................................8 3
9. 2. 3. Criteri a f or Assessi n g Effic ac y ........................................8 4
9. 2. 4. Criteri a f or Assessi n g T oler a bilit y ..................................8 4
9. 2. 5. H a n dli n g o f Dr o p o uts a n d Missi n g D at a ........................8 4
9. 2. 6. Ot her Iss ues ......................................................................8 4
9. 3. St atistic al Met h o ds a n d A n al ytic al Pl a n ..........................8 4
9. 3. 1. De m o gr a p hic a n d B aseli ne C h ar acteristics ....................8 4
9. 3. 2. Pri m ar y A n al yses .............................................................8 5
9. 3. 3. Sec o n d ar y A n al yses ..........................................................8 6
9. 3. 4. S afet y A n al yses ................................................................. 8 8
9. 3. 5 . Ot her A n al yses ................................................................. 8 8
1 0. S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S .............8 9
1 0. 1. P osti n g of I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al 
Tri als Re gisters ...............................................................8 9
1 0. 2. Re g ul at or y a n d Et hic al C o nsi der ati o ns, I ncl u di n g t he 
I nf or me d C o nse nt ...........................................................8 9
1 0. 3. Q u alit y C o ntr ol ( St u d y M o nit ori n g) ..............................9 0
1 0. 4. Q u al it y Ass ur a nce...........................................................9 0
1 0. 5. C o n diti o ns f or Ter mi n ati n g t he St u d y ...........................9 1
1 0. 6. Rec or ds Rete nti o n ...........................................................9 2
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 of 1 2 2

1 0. 7. Pr o visi o n of St u d y Res ults t o I n vesti g at ors, p osti n g of 
I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als 
Re gisters a n d P u blic ati o n ...............................................9 3
1 1. R E F E R E N C E S ..................................................................9 4
1 2. A P P E N DI C E S
.........................................................................................1 0
0
1 2. 1. A p pe n di x 1 - A b bre vi ati o ns a n d Tr a de m ar ks ...............1 0 0
1 2. 2. A p pe n di x 2 - Pr o d uct N utriti o n al Pr ofile ......................1 0 2
1 2. 3. A p pe n di x 3 - P are nt/ L A R re p orte d S y m pt o m C hec klist
.........................................................................................1 0 3
1 2. 4. A p pe n di x 4 - Pr o d uct C o m pli a nce Re p ort ....................1 0 6
1 2. 5. A p pe n di x 5 - Di a g n osis F or m ( D F) ................................1 0 7
1 2. 6. A p pe n di x 6 - 2 4 h o ur Diet ar y Rec all ..............................1 1 0
1 2. 7. A p pe n di x 7 - Diet ar y Di versit y Q uesti o n n aire ..............1 1 3
1 2. 8. A p pe n di x 8 - Diet ar y C o u nselli n g Sessi o ns ...................1 1 4
A. Diet ar y C o u nselli n g Sessi o ns F or P are nts/ L A Rs .................1 1 4
B. Diet ar y C o u nselli n g Sessi o ns F or C hil dre n .........................1 1 9
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 1 of 1 2 2

P R O C E S S F O R A M E N DI N G T H E P R O T O C O L
Pr ot oc ol  mo dificati o ns t o o n g oi n g st u dies w hic h c o ul d p ote ntiall y a d versel y affect t he 
safety of  parti ci pa nts or w hi c h alter t he sc o pe of t he i n vesti gati on, t he scie nt ific 
q u alit y of  t he st u d y, t he e x peri me ntal desi g n, d osa ges, d urati o n of t hera p y, 
assess me nt varia bles, t he n u m ber of parti ci pa nts treate d, or s u bject selecti o n criteria 
are c o nsi dere d maj or/s u bsta nt ial a me n d me nts a n d m ust be ma de o nl y after 
a p pr o priate c o ns ultat i on bet wee n a n a p pr o priate re prese ntati ve of G S K C H a n d t he 
i n vesti gat or.
Details o f a me n d me nts t o t he pr ot oc ols s h o ul d be rec or de d o n t he f o ll owi n g pa ge. 
Pr ot oc ol  mo dificati o ns m ust be pre pare d b y  a re prese ntati ve of G S K C H.  All c ha n ges 
m ust be j ust ifie d in t he Reas o n f or A me n d me nt secti o n of t he f o ll owi n g Pr ot oc ol  
A me n d me nt Pa ge. A p pr o val of a me n d me nts will be ma de b y t he ori gi nal pr ot oc ol 
sig n at ori es or t heir a p pr o priate desig nees.
All maj or/s u bsta nt ial pr ot oc ol  mo dificat i ons m ust be re vie we d a n d a p pr o ve d b y t he 
a p pr o priate I R B/I E C i n acc or da nce wit h l ocal re q uire me nts, bef ore t he re vise d 
e ditio n ca n be i m ple me nte d. 
All n o n-s u bsta nt ial/ mi n or/ a d mi nistrati ve a me n d me nts s h o ul d be s u b mitte d t o t he 
I R B/ I E C as per c o u ntr y s pecific re q uire me nts. I n s o me c o u ntries pre-a p pr o val of a 
mi n or a m e n d me nt is n ot re q uire d a n d will j ust be hel d o n file b y t he s p o ns or a n d 
i n vesti gat or.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 2 of 1 2 2

P R O T O C O L A M E N D M E N T P A G E
Details o f all a me n d me nts s h o ul d be rec or de d i n t he ta ble bel o w. Affecte d secti o ns s h o ul d be liste d i n t he ta ble; t he act ual 
a me n d me nt/ c ha n ge s h o ul d be ma de i n t he rele va nt secti o n of t he mai n pr ot oc ol. 
T o hi g hli g ht t he c ha n ge, t he f o ll owi n g feat ures will be use d: 
T o a d d te xt: Use of C A PI T A L L E T T E R S, B O L D A N D U N D E R LI N E
T o delete te xt: Use of Striket hr o u g h e. g. stri ket hr o u g h
A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 1
N o n -S u bsta nt ial/ Mi n or    Re d uc ti o n i n Zi nc le vel o n 
test pr o d uct
Zi nc l e vel has bee n re d uce d 
s o t hat its ma xi m u m val ue 
(incl u di n g o vera ges) i n t he 
test pr o d uct a n ytime re mai ns 
wi t hi n b ot h rec o m me n de d 
a n d safe li mit s.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 1 2. 2
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 3. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 2
N o n -S u bsta nt ial/ Mi n or    C h a n ge i n pr o d uct 
f or m ul ati o n c o de
T he test pr o d uct f or mulati o n 
has bee n re vise d basis t he 
re vise d Z n le vels a n d s o has 
I nf or me d 
C o nse nt  
Ye s 
N o
S afet y 
State m e nt     
Ye s 
N o
1.
Bri ef 
s u m mar y 
2.
Secti o n 5. 1
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 3. 0
S u bsta nt ial/ Maj or           
Date :
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
bee n t he f or m ulati o n c o de.
C R F                       
Ye s 
N o
A me n d me nt 
N o.: 3
N o n -S u bsta nt ial/ Mi n or    I ncl usi o n of ‘desi g n ate d 
C o ntr act Rese arc h 
Or g a nis ati o n ( C R O) ’ i n t he 
te xt rel ate d t o g ui di n g 
p olicies a n d st a n d ar d 
o per ati n g pr oce d ures u n der
st u d y g o ver n a nce
T o cl arif y te xt wit h re gar ds t o 
C R O m a na ge me nt acti vit ies.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 1 0. 2
2.
Secti o n 1 0. 3
3.
Se ctio n 1 0. 5
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 3. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 4
N o n -S u bsta nt ial/ Mi n or    P utti n g me as ures i n pl ace 
i n re g ar d t o st or a ge a n d 
dis p os al of H u m a n 
Bi ol o gic al S a m ple s ( H B S)
T o clar if y te xt wit h re gar d t o 
st ora ge a n d dis p os al  of H B S,
co n di tio ns s uc h as a) 
iss ua nce of st u d y re p ort, b) 
e x pir y of sta bilit y at - 7 0°C 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 6. 9
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4 . 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
a n d c) wi t hdra wal  of c o nse nt
f or a nal ysis of  sa m ples, ha ve 
bee n s pecifie d .
A me n d me nt 
N o.: 5
N o n -S u bsta nt ial/ Mi n or    All o wi n g s u pi ne p ositi o n 
als o f or bl o o d c ollecti o n.
C ollect i n g bl o o d fr o m 
c hil dre n i n lie d o w n p osi tio n
o n be d will be l ess pai nf ul 
a n d ca n a v o i d pa nic.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 
6. 9. 1. 3
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 6
N o n -S u bsta nt ial/ Mi n or    S pecif yi n g t y pes of t o pic al
a nest hetic t o be a p plie d 
bef ore c ollecti n g bl o o d 
s a m ples
F or better clarit y,  e xa m ples
f or t o pical a nest het ic 
oi nt me nt  s uc h as li d ocai n, 
tet racai n etc are a d de d.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 
6. 9. 1. 3
Si g nat ure:
D ate:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 7
N o n -S u bsta nt ial/ Mi n or    S electi o n criteri o n of 
sc h o ols bei n g l oc ate d i n 
peri -u r b a n are as h as bee n 
re m o ve d.
T o a v oi d a n y  r estrict i on a n d 
a m bi g uit y a n d t hus 
facilitati n g selecti on of 
sc h o ols, s uc h criteria is 
o mitte d.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 3. 4 
2.
Secti o n 6. 1
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 8
N o n -S u bsta nt ial/ Mi n or    Se verit y cl assific ati o n of GI 
a n d res pir at or y ill nesses as 
assesse d b y p h ysici a n gi ve n 
i n secti o n 6. 1 1. 2 is t o be 
m o difie d a n d t o be d o ne as 
per criteri a s pecifie d i n 
a p pe n di x 5.
T here i s sli g ht mis matc h i n 
se verity classificat i on b y 
p h ysicia n as descri be d i n 
secti on 6. 1 1. 2 a n d a p pe n di x 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 
6. 1 1. 2
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
5. T o m a ke it u nif or m , 
assess me nt of se verit y of  
ill nesses is t o be d o ne as per 
criteria me nt i one d i n 
a p pe n di x 5.
A me n d me nt 
N o.: 9
N o n -S u bsta nt ial/ Mi n or    List of st u d y sites (sc h o ols) 
is m o difie d.
S o m e of pre vio usl y  selecte d 
sc h o ols ha ve o pte d o ut of t he
st u d y. Ne w sc h o ols ha ve n o w 
bee n selecte d i ncl u di n g o ne 
as bac k u p.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
S u m mar y  
I nf or mat i on
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 1 0
N o n -S u bsta nt ial/ Mi n or    Vit a m i n B 6 a n d C are 
re m o ve d fr o m list of 
micr o n utrie nts t o be 
a n al yse d i n bl o o d.
D ue t o bl o o d sa m ple 
pr ocessi n g (ce ntrif u gati o n) 
re q uisites nee de d f or 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Pr ot oc ol  
s y n o psis
2.
Secti o n 2
3.
Secti o n 3. 1
4.
Secti o n 9. 3. 3
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Dat e:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
a nal ytes, viz., Vita mi n B 6 
a n d C, it w o uld be diffic ul t t o 
mai ntai n t heir sta bilit y i n t he 
c ollecte d sa m ples. T h us 
c o nsi deri n g feasi bilit y,  
parti c ularl y at site (sc h o ols), 
Vi ta mi n B 6 a n d C ha ve bee n 
dr o p pe d fr o m t he list of 
micr o n utrie nts pla n ne d t o be 
a nal yse d i n t he st u d y. 
A me n d me nt 
N o.: 1 1
N o n -S u bsta nt ial/ Mi n or    F ull f or ms of a b bre vi ati o ns 
e. g. H B S a n d C T C A E are 
s pecifie d. 
T hese a b bre viat i ons were 
misse d t o be defi ne d i n 
‘A b bre viati o ns a n d 
Tra de mar ks ’ a p pe n di x of 
pre vi o us versi o n of pr ot oc ol .
I nf orme d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 1 2. 1
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 1 2
N o n -S u bsta nt ial/ Mi n or    Initi al H B S st or a ge 
te m per at ure a n d d ur ati o n 
s pecific ati o ns, i m me di atel y 
after its c ollecti o n , h a ve 
bee n c h a n ge d 
I mme diatel y after c ollecti o n 
of  H B S it is more a p pr o pri ate 
t hat t he y are st ore d f or n ot 
m o re t ha n 4 hrs at 2-8 C o. 
T h us i nit ial H B S st ora ge 
t e mperat ure a n d d urati o n
s pecificati o ns, i m me diatel y 
aft er its c ollect i on, ha ve bee n 
c ha n ge d fr o m ‘less t ha n 4 Co
f or n o lo n ger t ha n 2 4 hr s’ t o 
‘ 2-8 C o f or n o lo n ger t ha n 4 
hrs’ .
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 6. 9
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 1 3
N o n -S u bsta nt ial/ Mi n or    Versi o n n u m ber of P ulse 
C O O xi meter ( M asi m o 
Pr o nt o) , t he i nstr u me nt t o 
be use d t o me as ure H b , will 
be re m o ve d.
Ne wer versi o n of n o n 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
1.
Secti o n 6. 9
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
i n vasi ve s pectr o p h ot o metr y 
base d i nstr u me nt ( Masi m o 
Pr o nt o 7 P ulse C O O xi meter)
is a vaila ble n o w. We ma y use
a differe nt (a n d n ot Pr o nt o 7) 
versi o n of t his i nstr u me nt i n 
t he st u d y. T h us t he versi on 
n u m ber of t he i nstr u me nt will 
n ot be s pecifi e d i n t he 
pr ot oc ol  t o a v oi d pr ot oc ol 
de viat i on.
C R F                       
Ye s 
N o
A me n d me nt 
N o.: 1 4
N o n -S u bsta nt ial/ Mi n or    Size of v ac ut ai ners t o 
c ollect bl o o d s a m ples is 
c h a n ge d
I nstea d of 7 ml size d 
vac utai ner, bl o o d sa m ples 
will be c o llecte d i n t w o 3. 5 
ml size d vac utai ners. T otal  
c ollecte d bl o o d v ol u me will 
r e mai n sa me.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                    
Ye s 
N o
1.
Secti o n 
6. 9. 1. 3
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 1 5
N o n -S u bsta nt ial/ Mi n or    T y p o err or of bl o o d 
c ollecti o n ti m e p oi nt is 
c orrecte d
Bl o o d c ollecti o n ti mi n g is 
i na d verte ntl y me nt i one d at 
‘ baseli ne a n d scree ni n g’ 
i nstea d of ‘ baseli ne a n d e n d 
of  st u d y’.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 
6. 9. 1. 3
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
Date:
A me n d me nt 
N o.: 1 6
N o n -S u bsta nt ial/ Mi n or    T y pe of vi al t o c ollect uri ne 
s a m ples f or l act ul ose 
m a n nit ol is c h a n ge d
I nstea d of s pecifie d cr yo-
vials, differe nt vials (ria 
vials) will be use d.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Secti o n 
6. 9. 1. 1
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 1 7
N o n -S u bsta nt ial/ Mi n or    T y pe of vi al t o c ollect uri ne 
s a m ples f or uri n ar y 
ne o pteri n test is c h a n ge d
I nstea d of s pecifie d cr yo-
vials, differe nt vials (c o nical 
b ott o m  t u bes) will be use d.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
1.
Secti o n 
6. 9. 1. 1
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
Ye s 
N o
A me n d me nt 
N o.: 1 8
N o n -S u bsta nt ial/ Mi n or    List of st u d y site s (sc h o ols) 
is m o difie d.
S o m e of pre vio usl y  selecte d 
sc h o ols ha ve o pte d o ut of t he
st u d y. Ne w sc h o ols ha ve n o w 
bee n selecte d i ncl u di n g t w o 
as bac k u p.
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
S u m mar y  
I nf or mat i on
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 1 9
N o n -S u bsta nt ial/ Mi n or    Or der of acti vities f or 
b aseli ne a n d e n d of st u d y 
visit will n ot be s pecifie d .
Or der of h u ma n bi o l ogical  
sa m ples ( bl o o d, sali va a n d 
uri ne) c ollect i on will be 
f oll owe d as per o perati o nal 
feasi bility a n d c o n ve nie nce 
of  c hil dre n at sites. 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
1.
Pr ot oc ol  
s y n o psis
2.
Secti o n 3. 1 
St u d y  desi g n
Si g nat ure:
Pr ot oc ol
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 2 0
N o n -S u bsta nt ial/ Mi n or    L ast S t u d y P h ysici a n 
W ee kl y R e vie w c o n d uct 
d a y of t he st u d y is s pecifie d .
C urre nt l y last S P W R c o n d uct 
d a y  is s pecifie d wi t h res pect 
t o pr o d uct a d mi nistrati o n 
o nl y . T h us it is a p plica ble t o 
test gr o u p a n d n ot f or c o ntr ol 
gr o u p. T h us, s o as t o 
sta n dar dize it i n b ot h t he 
gr o u ps , last S P W R will be 
c o n d ucte d o n e n d of st u d y 
visit da y , e ve n if s y m pt o ms 
are assesse d f or less t ha n a 
wee k i n s y m pt o m c hec klist 
f or m. 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 2 1
N o n -S u bsta nt ial/ Mi n or    Ti meli ne f or w r iti n g 
st atistic al re p orti n g a n d 
a n al ysis pl a n of st u d y is 
c h a n ge d.
I n c o mplia nce wi t h G S K 
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
1.
Secti o n 9. 3
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 5. 0
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
P P D
P P D
P P D
P P D

A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
S O P, t i meli ne of  writin g 
statistical re p orti n g a n d 
a nal ysis pla n is c ha n ge d fr o m 
‘pri or t o st u d y  start (first 
s u bject first visit ( F S F V)’ t o 
‘st u d y a nal ysis ’.
C R F                       
Ye s 
N o
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

S C H E D U L E O F E V E N T S
Acti vit y
Visit 1
Visit 2
Diet ar y C o u nsel li n g Visits1
Visit 3: Sessi o n 1 -Da y 1 -3 of Wee k 1 fr o m B V
Visit 4: Sessi o n 2 -Wee k 2 fr o m B V + u p t o 3 da ys
Visit 5: Sessi o n 3 -Wee k 6 fr o m B V + u p t o 3 da ys
Visit 6: Sessi o n 4 -Wee k 1 0 fr o m B V + u p t o 3 da ys
Visit 7: Sessi o n 5 -Wee k 1 4 fr o m B V + u p t o 3 da ys
Visi t 8: Sessi o n 6 -Wee k 1 8
fr o m B V + u p t o 3 da ys
Visit 9: Sessi o n 7 -Wee k 2 2
fr o m B V + u p t o 3 da ys
S P W R & p are nt/ L A R 
s y m pt o m c hec klist
Visit 1 0
Scree ni n g 
Visit
B aseli ne Visit 
( + 1 t o 2 1 d a ys 
p ost scree ni n g 
visit)
E n d of St u d y Visit 
( + 1 t o 7 d a ys p ost 
e n d of 9 m o nt h 
fr o m b aseli ne 
visit )
I nf or me d c o nse nt a n d asse nt2
X
S P W R will i nitiate 1 wee k 
( + u p t o 2 da ys) p ost first 
dietar y c o u nselli n g visit of 
t he partici pa nt a n d will 
c o nti n ue o n a wee kl y basis ( + 
u p t o 2 da ys) u ntil E n d of 
St u d y Visit.
Pare nt/ L A R s y m pt o m 
c hec klist & Pr o d uct 
C o m plia nce Re p ort F or ms 
will be c ollecte d a n d 
re vie we d f or eac h wee kl y 
re vie w wit h t he p h ysicia n
De m o gra p hics
X
Me dical hist or y
X
C urre nt/c o nc o mita nt 
me dicati o n
X
X
X
X
Ge neral p h ysical e xa mi nati o n
X
X
Vital si g ns
X
X
Hb  assess me nt usi n g Pr o nt o
X
A nt hr o p o metric meas ure me nts 
( hei g ht, wei g ht , B MI a n d 
H A Z )
X
X
I ncl usi o n/e xcl usi o n criteria 
e val uati o n
X
S u bject Eli gi bilit y
X
2 4 hr dietar y recall & Dietar y 
Di versit y S ur v e y
X
X
Pare ntal/ L A R tr ai ni n g t o 
c o m plete ‘s y m pt o m c hec k list’ 3
X
Dis pe nse bla n k Pare nt/ L A R 
s y m pt o m c hec klist a n d Pr o d uct 
C o m plia nce Re p ort F or ms 
X
C o nti n ue d eli gi bilit y criteria
X
X
X
Sa m ple c ollecti o n f or uri nar y 
ne o pteri n test &
lact ul ose/ ma n nit ol test
X
X
S a m ple c ollecti o n f or a nal ysis 
of ser u m ferriti n, s Tf R, C R P, 
A G P, sI g A & n utriti o nal 
bi oc he mistr y
X
X
Dietar y c o u nselli n g
X
Pr o d uct a d mi nistrati o n
(a p plica ble t o test gr o u p o nl y) 4
X
Pr o d uct c o m plia nce c hec k & 
c ollect e m pt y pr o d uct sac het
( a p plica ble t o test gr o u p o nl y)
X
A E m o nit ori n g
X
X
X
St u d y C o m pleti o n a n d me dical 
si g n off
X
                                               
1 Sessi o n n u m ber 3, 4, 5, 6 a n d 7 ca n be p ost p o ne d i n vie w of l o n g sc h o ol h oli da ys a n d e xa ms. Sessi o n n o 7 will n ot be c o n d ucte d a n y 
later t ha n t he last da y of 8t h m o nt h of i nte r ve nti o n peri o d. A mi ni m u m of 4 wee ks ga p m ust be mai ntai ne d bet wee n sessi o n n u m ber 2, 3, 
4, 5, 6 a n d 7 .
2 O btai ni n g i nf or me d c o nse nt a n d asse nt a n d perf or mi n g scree ni n g acti vities ca n be o n differe nt dates b ut i nf or me d c o nse nt a n d asse nt 
will be o btai ne d pri or t o perf or mi n g a n d a p pl yi n g a n y scree ni n g criteria or pr oce d ures.
Scree ni n g acti vities s h o ul d be wit hi n 6 0 da ys of 
o btai ni n g c o nse nt a n d asse nt.
3 Ca n be d o ne a n yti me p ost o btai ni n g C o nse nt & Asse nt b ut pri or t o baseli n e visit .
4 I nter ve nti o n be gi ns + 1 t o 3 da ys fr o m baseli ne visit a n d c o nti n ues f or 9 m o nt hs. C o m plia nce c hec k, test pr o d uct e m pt y sac hets will be 
c ollecte d a n d A E will be rec or de d t hr o u g h o ut t he i nter ve nti o n peri o d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 5 of 1 2 2

P R O T O C O L S Y N O P SI S F O R S T U D Y 2 0 4 4 7 7
Brief S u m m ar y
T he i m p orta nce of p u blic healt h i nter ve nti o n lies wit h t he c o nce pt of t he ‘ C o nti n u u m 
of  care’ a p pr oac h. While t here alrea d y e xist s a lot of  i nf or mati on o n t he pre vale nce of 
n utri tio nal i na de q uac y a n d its effects o n m o r bi dit y a n d mortali t y fr om c o m m o n 
c hil d h o o d ill nesses f or c hil dre n u n der 5 y ears of a ge, u nf ort u natel y , si milar 
i nf or mat i on o n c hil dre n ol der t ha n 5 y ears of  a ge is scarce. A n utri tio nal  int er ve nt i on 
pr o gra m will  be nefit a n a d olesce nt a ge gr o u p ( 1 1 -1 9 years) o nl y if t he r e is c o nt i n uity 
of  care f or pri mar y sc h o ol a ge c hil dre n ( 6 -1 0 years) als o. 
T here i s a wi de-s prea d pre vale nce of c o nc urre nt micr o n utrie nt deficie ncies , e ve n i n 
a p pare nt l y n or m al sc h o ol a ge c hil dre n i n I n dia. S o met i mes e ve n a p pare nt l y heal t h y 
sc h o ol c hil dre n ma y ha ve s u b -cli nical deficie ncies. Vari o us st u dies a n d d ietar y 
s ur ve ys s uc h as t h ose c o n d ucte d b y t he I n dia n C o u ncil of Me dical  Researc h i n dicate 
t hat t he micr o n utrie nt i nta kes of sc h o ol a ge c hil dre n i n I n d ia are muc h bel o w t he 
rec o m me n de d le vels. 
A de q uate a m o u nts of  micr o n utrie nts are re q uire d f or t he i m m u ne s yste m t o f u ncti o n
effect i vel y. Micr o n utrie nt deficie ncies ca n ha ve far -reac hi n g health c o nse q ue nces, 
c o ntri b uti n g t o i m pair me nts i n gr o wt h, ne ur o be ha vi oral f u nct i on, a n d i m m u ne 
c o mpete nce, as well as i ncreases i n m or bi dity a n d m ortalit y . Micr o n utrie nt 
deficie ncies a n d c hil d h o o d m or bi dit ies ha ve bee n f o u n d t o c o -e xist. Macr o n utrie nts 
als o ha ve si g nifica nt r ole t o pla y i n pr o per f u nct i ons o f i m m u ne s yste m. Pr otei n -
e ner g y mal n utrit i on is k n o w n t o ca use i m paire d i m m u nity a n d i ncrease d 
s usce pti bility t o i nfecti ons. Ma n y cells o f t he i m m u ne s yste m de pe n d f or t heir 
f u ncti on o n meta b o lic pat h wa ys. I n I n dia, t he m ost c o m m o n diseases e nc o u ntere d 
d uri n g c hil d h o o d are diarr h o ea a n d ac ute res pir at or y ill nesses ( A RIs). T hese ill nesses
are a t hreat t o t he n or mal gr o wt h a n d de vel o p me nt of a c hil d. 
T he rel at i ons hi p bet wee n micr o n utrie n t deficie nc y a n d mor bi di ties or mortali ties 
fr om ill ness i n sc h o ol a ge c hil dre n are well-d oc u me nte d; b ut, t here is a deart h of 
e vi de nce o n t he effect i ve ness of m ulti ple n utri e nt ( MN) s u p pl e me ntatio n o n t hese 
para m eters i n sc h o ol a ge c hil dre n.
T heref ore, t h is cli nical st u d y is pr o p ose d t o test t he h yp ot hesis t hat a f ortifie d malt 
base d f o o d ma y hel p i m pr o ve i m m u nit y o utc o m es i n sc h o ol c hil dre n 7 t o 1 0 y ears of 
a ge. T his st u d y will be f u n de d b y Gla x o S mi t hKli ne C o ns u mer Healt hcare ( G S K C H )
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 6 of 1 2 2

a n d will be r u n i n I ndia as a cluster ra n d o mise d, o pe n la bel c o ntr olle d st u d y. 
P arti cipa nt s will be recr uite d fr om sc h o ols i n I n dia.
O bjecti ves a n d E n d p oi nts
O bjecti ves
E n d p oi nts
Pri m ar y

T o de ter mi ne t he t otal n u m ber of 
ill da ys d ue t o gastr oi nt est i nal 
( GI) a n d res pirat or y ill nesses i n 
parti ci pa nt s recei vi n g f ortifie d 
malt base d f o o d (test pr o d uct) 
wi t h diet ar y c o u nselli n g i n 
c o mparis o n t o partici pa nt s 
recei vi n g o nl y dietar y  c o u nselli n g 
o ver a peri o d of ni ne m o nt hs.

T otal  n u m ber of ill da ys d ue t o GI
a n d res pirat or y ill nesses.
Sec o n d ar y

T o c o m pare t he f oll owi n g 
para m eters i n parti ci pa nt s 
recei vi n g t he f ortifie d malt base d 
f oo d (test pr o d uct) al o n g wit h 
di et ar y c o u nselli n g t o partici pa nt s 
receivi n g o nl y dietar y  c o u nselli n g 
o ver a peri o d of ni ne m o nt hs:
1.
Fre q ue nc y of GI a n d res pirat or y 
ill nesses.
1. N u m ber of e pis o des of GI a n d 
res pir at or y ill nesses.
2.
Se verit y of  GI a n d res pirat or y 
ill nesses.
2. Se verit y of  GI a n d res pirat or y 
ill nesses.
3.
Sc h o ol  a bse nteeis m d ue t o GI a n d 
res pir at or y ill nesses.
3. Sc h o ol a bse nteeis m d ue t o GI a n d 
res pir at or y ill nesses.
4.
C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n b o d y  mass i n de x 
( B MI).
4. B MI at scree ni n g a n d e n d o f 
st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 7 of 1 2 2

5.
C ha n ge fr o m baseli ne i n g ut 
i nte grit y/ he alt h as meas ure d b y 
Lact ul ose Ma n nit o l test.
5. G ut i nte grit y/ healt h as meas ure d 
b y Lact ul ose Ma n ni t ol test at 
baseli ne a n d e n d of st u d y .
6.
C ha n ge fr o m baseli ne i n g ut 
i nte grit y/ he alt h as meas ure d b y 
Uri nar y  Ne o pteri n test.
6. G ut i nte grit y/ healt h as me as ure d 
b y Uri nar y  Ne o pteri n test at baseli ne 
a n d e n d of st u d y.
7.
C ha n ge fr o m baseli ne i n m uc osal 
i m m u nity as meas ure d b y 
Sali var y  I m m u n o glo b uli n A (I g A) 
stat us.
7. Sali var y I m m u n o gl o b uli n A (I g A) 
stat us at  baseli ne a n d e n d of st u d y.
8.
C ha n ge fr o m baseli ne i n le vels of 
micr o n utrie nts Vi ta mi n A, B 6,
B 1 2, C , D ( 2 5-
h y dr o x yc h o lecalcifer ol), E, f olate, 
of  t he trace ele me nts sele ni u m, 
zi nc, c o p per, a n d ir o n as 
deter mi ne d b y bl o o d dra w a n d 
a nal ysis.
8. Le vels of micr o n utrie nts Vi ta mi n
A, B 6, B 1 2, C , D ( 2 5-
h y dr o x yc h o lecalcifer o l), E, f olat e, of 
t he trace ele me nts sele ni u m, zi nc, 
c o p per, a n d ir o n at baseli ne a n d e n d 
of  st u d y
9.
C ha n ge fr o m baseli ne le vels o f 
ferritin, ser u m tra nsferri n rece pt or 
(s Tf R), C-reacti ve pr otei n ( C R P), 
a n d Al p ha 1 -acid gl yc o pr otei n 
( A G P) as deter mi ne d b y bl o o d 
dra w a n d a nal ysis.
9. Le vels of ferritin, ser u m 
tra nsferri n rece pt or (s Tf R), C-
reacti ve pr otei n ( C R P), a n d Al p ha 1-
acid gl yc o pr otei n ( A G P) at baseli ne 
a n d e n d of st u d y.
1 0. C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n dietar y di versity
sc ore, assesse d t hr o u g h 2 4 -h o ur 
I n di vi d ual Dietar y Di versit y 
Sc ore (I D D S)
1 0. Di et ar y di versit y sc ore assesse d 
t hr o u g h 2 4-h o ur I D D S at scree ni n g 
a n d e n d of st u d y.
1 1. C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n e ner g y, pr otei n, 
car b o h y drates a n d fat 
c o ns u m ptio n, assesse d t hr o u g h 
1 1. I nta ke of e ner g y , pr otei n, 
car b o h y drate, a n d fat fr o m 2 4- h o ur 
di et ar y recall s ur ve y at scree ni n g a n d 
e n d of st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 8 of 1 2 2

2 4 -h o ur dietar y  recall s ur ve y
St u d y Desi g n
O ver all Desi g n
T his is a si n gle ce ntre, m ulti ple sites, o pe n la bel , t w o-ar m, parallel-gr o u p, stratifie d 
b y ge n der, matc he d pair cl uster ra n d o mise d, c o ntr olle d st u d y.
Visit 1 - Scree ni n g Visit
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n p ost ra n d o misati on
of  clust ers :

I nf or me d c o nse nt a n d asse nt

D e m o gra p hics

Me dical hist or y

C urre nt/c o nc o mita nt me dicati o n s

Ge neral p h ysical e xa mi nat i on

Vi t al si g ns

H b assess me nt  usi n g Pr o nt o

A nt hr o p o m etric meas ure me nts ( h ei g ht a n d w eig ht)

I ncl usi on/e xcl usi o n cri teria e val uati o n

S u bject Eli gi bilit y

2 4 hr di etar y recall & di et ar y di versity s ur ve y

Pare ntal / L A R trai ni n g o n t he c o m plet i on of t he ‘ Sy m pt o m  Chec k L ist’

Di s pe nse bla n k Pare nt/ L A R S y m pt o m C hec klist a n d Pr o d uct C o m plia nce 
Re p ort F or m s
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 2 9 of 1 2 2

Visit 2 - B aseli ne Visit
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:

C urre nt/c o nc o mita nt me dicati o n s

C o nti n ue d e li gi bility cri t eria

S a m ple c ollect i on f or u ri nar y N e o pt eri n test & la ct ulose/ m a n nit ol test

S a m ple col lecti on f or a nal ysis of ser u m ferritin, s Tf R, C R P, A G P, s I g A & 
n utri tio nal b i oc he mistr y (f or micr o n utrie nts vita mi ns A, B 6, B 1 2, C, D, E, 
f olate, a n d of t he trace ele me nts sele ni u m, zi nc, c o p per, a n d ir o n)

A d ver se E ve nt ( A E) m o nit ori n g
Visit 3, 4, 5, 6, 7 , 8, 9, S P W R a n d Pr o d uct A d mi nistr ati o n Visits
T he f o ll owi n g assess me nts will be c o n d ucte d:

C urre nt/c o nc o mita nt me dicati o ns

C o nti n ue d eli gi bilit y cri t eria

Di et ar y c o u nselli n g will be a d mi nistere d t o a ll st u d y partici pa nts a n d t heir 
pare nts/ L A Rs.

Test pr o d uct will be a d mi nistere d t o all st u d y  participa nts i n t he test gr o u p
o nl y .

S P W R visits will be c o n d ucte d o n a wee kl y basis u nt il E n d of  St u d y Visit.
Pare nt/ L A R s y m pt o m c hec klist & Pr o d uct C o m plia nce Re p ort F or ms will  be 
c ollecte d a n d re vie we d .

A d verse E ve nt ( A E) m o nit ori n g
Visit 1 0 - E n d of St u d y Visit
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:

C urre nt/c o nc o mita nt me dicati o n

Ge neral p h ysical e xa mi nat i on
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 0 of 1 2 2


Vi t al si g ns

A nt hr o p o m etric meas ure me nts ( h ei g ht a n d w eig ht)

C o nti n ue d e li gi bility cri t eria

2 4 hr di etar y recall & di et ar y di versity s ur ve y

S a m ple c ollect i on f or u ri nar y Ne o pteri n test & la ct ulose/ m a n nit ol test

S a m ple col lecti on f or a nal ysis of ser u m ferritin, s Tf R, C R P, A G P, s I g A & 
n utri tio nal b i oc he mistr y (f or micr o n utrie nts vita mi ns A, B 6, B 1 2, C , D, E, 
f olate, a n d of t he trace ele me nts sele ni u m, zi nc, c o p per, a n d ir o n)

A E m o ni t ori n g

St u d y  c o mplet i on a n d m e dical si g n-of f
T y pe a n d Pl a n ne d N u m ber of P artici p a nts
A p pr o xi matel y  1 3 0 0 parti ci p a nts will be scree ne d i n at least 4 cl usters ( wit h at least 2 
clust ers per st u d y  ar m), t o ra n d o mise a p pr o xi matel y 9 2 4 part ici pa nts t o e ns ure 6 4 6
e val ua ble part ici pa nts c o mplete t he e nt ire st u d y. T his will e ns ure at least 3 2 3
e val ua ble part ici pa nts per stu d y ar m.
Di a g n osis a n d M ai n Criteri a f or I ncl usi o n
B o ys a n d girls, a ge d 7 t o 1 0 y ears i ncl usi ve wit h H A Z of  ≥- 3 t o ≤- 1 will be i n vite d t o 
parti ci pate i n t his st u d y.
Pr o d uct I nf or m ati o n
Test Gr o u p
C o ntr ol Gr o u p
Pr o d uct N a me 
F ortifie d mal t base d f o o d
N o treat me nt
Pr o d uct F or m ul ati o n 
C o de
N/ A
D ose
2 7 gra ms
N/ A
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 1 of 1 2 2
C CI

R o ute of A d mi nistr ati o n
Oral
N/ A
D osi n g I nstr ucti o ns
2 7 gra ms p o w der ma de u p 
i n 1 5 0 m L l u ke war m water
a d mi nistere d t wice dail y
N/ A
St atistic al Met h o ds
T he pri mar y  efficac y v aria bl e of t he st u d y is t he i m pact of treat me nts o n t he n u m ber 
of  ill da ys. T he n u m ber of ill da ys will be a nal yse d usi n g t he a nal ysis of varia nce 
( A N O V A). T he A N O V A will ha ve treat me nt, clust er (sc h o ol) a n d ge n der as fi xe d
effects. C o m paris o ns will be ma de bet wee n test a n d c o ntr ol gr o u ps at 5 % si g nifica nce 
le vel. Ni net y- fi ve perce nt c o nfi de nce i nter vals will al s o be c o nstr ucte d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 2 of 1 2 2

1. I N T R O D U C TI O N
T he i m m u ne s yste m is t he b o d y’s defe nce a gai nst disease -ca usi n g or ga nis ms, 
malf u nct i oni n g cells, a n d f orei g n particles. F urt her, resista nce t o a disease -ca usi n g 
or ga ni s m or har mf ul s u bsta nce is ter me d “i m m u nity” . T his a bility t o offer resista nce 
t o a disease ca n bec o me c o m pr o mise d if n utrit i on is i na de q uate. 
S u bsta nt ial researc h has f oc use d o n t he r ole of n utrit i on a n d es peciall y o n t he 
c o ntri b uti o n o f vit a mi ns a n d mi nerals t o t he o pti m u m  fu nct i oni n g of t he i m m u ne 
s yste m. It has bee n de m onstrate d t hat a de q uate a m o u nt s of  micr o n utrie nts are 
re q uir e d for t he i m m u ne s yste m t o f u ncti on effect ivel y. A vaila ble data i n dicate a r ole 
f or vit a mi ns A, D, E, B 6, B 1 2, f olate, a n d vita mi n C, a n d of t he trace ele me nts 
sele ni u m, zi nc, c o p per, a n d ir o n i n t he pr o per w or ki n g of t he i m m u ne s yste m 
[ Wi nter gerst et al 2 0 0 7].
Micr o n utri e nt deficie ncies are wi des p rea d i n ma n y de vel o pi n g c o u ntries i n 
w hic hsta pl e diets are pre d o mi natel y rice -base d, i nta kes of a ni mal -s o urced f oo ds are 
l ow [ Wi nic ha g o o n P 2 0 0 2], a n d re gi o nal s oil i odi ne a n d zi nc le vels are l o w 
[ Wa narat na et al. 1 9 9 7 & All o wa y BJ 2 0 0 4]. C hil dre n are partic ularl y at ris k f or s uc h 
deficie ncies as a res ult of e xcessi ve l osses of ir o n, zi nc, a n d/ or vita mi n A arisi n g fr o m 
i nfecti ous di seases a n d/ or parasitic i nfecti ons [ Filt ea u S M et al. 1 9 9 4, K os ki K G et al. 
2 0 0 1 & E g ger RJ et al. 1 9 9 0]. I nteracti o ns bet wee n c o -e xist i n g deficie ncies of 
vit a mi n A a n d ir o n [ Bl oe m M W 1 9 9 5 & Bl oe m M W et al. 1 9 8 9] a n d vita mi n A a n d 
zi nc [ C hrist ian P et al. 1 9 9 8 & U d o m kes malee E et al. 1 9 9 2] ma y als o occ ur, w hic h 
ma y f urt her e xacer bate s o me of t hese micr o n utrie nt deficie nc y  states. S uc h 
deficie ncies ca n ha ve far -reac hi n g health c o nse q ue nces, c o ntri b ut i n g t o i m pair me nts 
i n gr o wt h, ne ur o be ha vi oral f u ncti on, a n d i m m u ne c o m pete nce, a n d i ncreases i n 
m o r bidi t y a n d mortali t y [ Vit eri FE et al. 2 0 0 2]. Macr o n utrie nts als o ha ve si g nifica nt 
r ole t o pla y in pr o per f u nct i ons of i m m u ne s yste m. Pr otei n -e ner g y mal n utritio n is 
k n o w n t o ca use i m paire d i m m u nit y a n d i ncrease s usce pt i bility t o i nfect i on. T he m ost 
c o nsiste nt c ha n ges i n i m m u ne c o m pete nce i n P E M are i n cell -me diate d i m m u nit y 
[ Mc M urra y D N et al. 1 9 8 1, C ha n dra R K 1 9 7 4]. De pressi o n of cell me diate d 
i m m u nity b y P E M c o ul d be t he res ult of a n a bs ol ute or relat i ve deficie nc y of a mi n o 
acids f or cell m ul tiplicat i on. M ore o ver, c hil dre n wit h P E M are k n o w n t o ha ve raise d 
le vels of pl as ma c ortis ol [ S oli ma n A T et al. 2 0 0 0], w hic h ca n affect t he t h y mic 
h or m o nes s y nt hesis fr o m t h y m ol y m p hatic s yste m a n d res ult i n re peate d i nfecti ons.
T here i s a wi de-s prea d pre vale nce of c o nc urre nt micr o n utrie nt deficie ncies, e ve n i n 
a p pare nt l y n or m al sc h o ol a ge c hil dre n i n I n dia. Acc or di n g t o a st u d y b y Si va k u mar et 
al ( 2 0 0 6), a sta g geri n g pr o p orti o n of health y sc h o ol c hil dre n ha ve s u b-cli nical 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 3 of 1 2 2

deficie ncies a n d/ or i na de q uate micr o n utrie nt i nta kes . A p pr o xi matel y 4 5-6 5 % of  t he 
sc h o ol c hil dre n ha d deficie ncies of vita mi ns B 2, B 6, an d B 1 2. St u dies s o far ha ve 
re p orte d a nae mia pre vale nce as hi g h as 4 2 t o 6 3 % i n t his a ge gr o u p [ G o m ber et al. 
2 0 0 3, K u mar et al. 2 0 0 3, Ra o et al. 1 9 8 0, Set hi et al. 2 0 0 3, Si va k u mar et al. 2 0 0 6].  
F urt her m or e, di et ar y s ur ve ys i n dicate t hat t he micr o n utrie nt i nta kes of sc h o ol a ge 
c hil dre n i n I n dia are m uc h bel o w (a p pr o xi matel y 3 0 -7 0 %) t he rec o m me n de d le vels 
[ Vija yra g ha va n et al. 2 0 0 0, Si va k u mar et al. 2 0 0 6, N N M B 2 0 0 6]. I n a rece nt 
ra n d omise d, d o u ble bli n d, place b o c o ntr olle d st u d y c o n d ucte d b y a n accre dite d 
aca de mic i nstit ute i n c olla b orati o n wit h Gla x o S mi t h Kli ne (G S K ) [ Vaz et al. 2 0 1 1], 
micr o n utrie nt deficie nc ies of  ri b ofla vi n a n d B 1 2 were f ou n d t o be 8 8 % a n d 1 7 %, 
res pecti vel y, i n a p pare ntl y heal t hy s c h o ol g oi n g c hil dre n ( 7- 1 0 years).
Micr o n utri e nt deficie ncies a n d c hil d h o o d m or bi dit ies ha ve bee n f o u n d t o c o-e xist 
[ Pat wari A K 1 9 9 9]. I n I n dia, t he m ost c o m m o n diseases e nc o u ntere d d uri n g 
c hil d h o o d are diarr hea a n d A RIs [ Sar kar et al. 2 0 1 3]. Ot her st u dies ha ve s h o w n t hese 
ill nesses t o be c o m m on acr oss t he de vel o p i n g w orl d [ Castr o et al. 2 0 0 3, H ussai n et 
al . 1 9 9 9].  T hese ill nesses are a t hreat t o t he n or mal gr o wt h a n d de vel o p me nt of a 
c hil d. 
Di arr hea a n d mal n utritio n of te n occ ur i n a vici o us c y cle, wit h o ne c o n ditio n 
per pet uati n g t he ot her .  It has bee n f o u n d t hat pre-e xist i n g n utri tio nal deficit s ca use 
re d uce d t ur n o ver of e pit helial cells of t he gastr oi ntesti nal ( GI) li ni n g, res ulti n g i n 
d el a ye d rec o ver y [ P at w ari A K 1 9 9 9]. Mal n utriti on ca n als o c o m pr o mise t he b o d y ’s 
d ef e nce mec ha nis m t here b y ma ki n g t he i ntest i nal li ni n g more v ul nera ble t o 
c olo n isatio n b y  pat h o ge nic micr o bes [ Pat wari A K 1 9 9 9]. Diarr hea, i n t ur n, ca uses 
f urt her l oss of n utrie nts [ B ha n dari et al. 2 0 1 4, T hac ker N. 2 0 0 7] a n d he nce a n 
e xacer bati o n of t he diarr hea a n d t he ma l n utritio n. Se veral e pi de mi o l ogi c al st u di es 
ha ve de m o nstrate d a ne gat i ve c orrelati on bet wee n diarr hea a n d p h ysical gr o wt h a n d 
de vel o p me nt [ Pat wari A K 1 9 9 9, T orres et al. 2 0 0 0].
Li k e di arr hea, A RIs are als o c o m m o n ill nesses d uri n g c hil d h o o d [ C o uriel J 2 0 0 2]. 
A RI s ca n f urt her be cate g orise d as u p per res pi rat or y tract i nfectio ns ( U R T Is) a n d 
l ower res pi r at or y tract i nfecti o ns ( L RT Is). T he u p per res pirat or y  tract muc osa i s t he 
pri mar y  sit e for r es pi rat or y vir us c o ntact [ Bartle y J 2 0 1 0]. U RT Is are k n o w n t o be t he 
m o st c o m mo n  a n d i ncl u de i nfectio ns li ke r hi nit is (c o m m on c o l d), si n usitis, ear 
i nfecti ons, ac ute p har y n git is, e pi gl ottis, a n d lar y n gitis [ Si m oes et al. Te xt C h 2 5]. 
S uc h i nfect i ons ha ve t he p ote ntial o f lea di n g t o se vere c o m plicati ons, t here b y 
affect i n g t he gr o wt h a n d de vel o p me nt of a c hil d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 4 of 1 2 2

Ma n y  st u dies ha ve de mo nstrate d t he efficac y  or t he p ote nti al i m p orta nce of  si n gle 
micr o n utrie nt s i n re d uci n g t he i nci de nce, d urati o n a n d or se verity of  t hese c o m mo n  
ill nesses i n c hil dre n. I n a d o u ble-bli n d, ra n d o mise d, place b o c o ntr olle d trial 
c o n ducte d i n I n dia n c hil dre n ; it was f o u n d t hat zi nc a d mi nistrati o n, alo ne,
sig nifica nt l y re d uce d t he i nci de nce of ac ute a n d pr ol o n ge d diarr hea. It als o re d uce d 
t he rec urre nce of diarr hea i n t hese c hil dre n [ B ha n dari et al. 2 0 1 4]. I n a p o ole d 
a nal ysis of ra n d o mise d c o ntr olle d trials, zi nc a d mi nistrati o n was de m o nstrate d t o 
e x pe dite rec o ver y fr o m diarr hea [ B h utta et al. 2 0 0 0]. Vita mi n D deficie nc y has bee n 
ass ociat e d wit h increase d i nci de nce a n d d urati o n of U R T Is acr oss a ges [ U ysal ol et al. 
2 0 1 3, C he n g -S hi u n et al. 2 0 1 3]. I n a st u d y c o n d ucte d i n sc h o ol a ge c hil dre n i n 
B o g ota, C ol o m bia, Vi ta mi n A deficie nc y w as fo u n d t o be ass oci ate d wit h increase d 
ris k of GI a n d res pirat or y mor bi di t y [ T h or nt o n et al. 2 0 1 4]. T he pr o p ose d mec ha nis m 
of  actio n of  Vita mi n A i n re d uci n g res pir at or y infecti o ns is t hr o u g h i ncrease d 
e x pressi o n of e nz y mes of t he al de h y de de h y dr o ge nase 1 A fa mil y (A L D H 1 A ) i n 
res pir at or y tract e pit helial cells [ R u draraj u et al. 2 0 1 4].
T h o u g h t hese st u dies de m o nstrate t he i m p orta nce or t he p ote ntial i m p orta nce o f 
micr o n utrie nts i n s u p p orti n g t he pr o per f u nct i oni n g of t he i m m u ne s yste m, i n n o 
st u d y has t he i m pact of an M N s u p ple me nt o n t hese para meters i n sc h o ol a ge c hil dre n 
i n I n dia bee n i n vesti gate d. C o rrecti n g n utriti onal i na de q uac y in sc h o ol  a ge c hil dre n is 
cr itical f or o pti misi n g c hil d gr o wt h a n d ca pacity t o lear n, t here b y b uil di n g a s oli d 
f ou n dat i on f or t he c hil d’s f ut ure. I ncrease d m or bi dity fr o m ill nesses t hat are c o m m on 
i n c hil d h o o d (s uc h as a greater fre q ue nc y of ill nesses, a l o n ger d urati o n of ill ness, or 
i ncrease d ill ness se verity)  is li kel y t o res ult i n i ncrease d sc h o ol a bse nteeis m, t here b y 
ne gat i vel y i m pacti n g t otal lear ni n g da ys a n d a bility.  T heref ore, it is of ut most 
sig nifica nce t o e val uate t he effect of M N s u p ple me ntati o n i n t his a ge gr o u p, gi ve n 
that deficie ncies are c hr o nic a n d wi del y pre vale nt. 
T o test t he h y p ot hesis t hat M N s u p pl e me ntatio n ca n fa v ora bl y i m pact i m m u ne 
f u ncti oni n g relat i ve t o n o MN s u p pl e me ntatio n, i n t he pr o p ose d cli nical st u d y , 
c hil dre n will be ra n d oml y all ocate d t o eit her f ort ifie d malt  base d f o o d (test) gr o u p or 
a c o ntr ol (refere nce) gr o u p 5.  All st u d y particip a nts (i rres pecti ve of gr o u p all ocati on), 
as well as t heir teac hers a n d t heir pare nts or le gall y acce pta ble re prese ntati ves 
( L A Rs), als o will recei ve a ge-s pecific dietar y c o u nseli n g t o o pti m ise n utritio nal 
i nta kes, base d o n t he Diet ar y G uideli nes f or I n di a ns, esta blis he d b y t he I n dia n 
                                               
5 T o ac hie ve d o u ble -bli n di n g, t he c hil dre n i n t he c o ntr ol gr o u p w o ul d ha ve t o be a d mi nistere d a n 
u nf ortifie d cal orie free pr o d uct. H o we ver, it was deter mi ne d t hat it w o ul d be u net hical t o a d mi nister a n 
“e m pt y-cal orie” pr o d uct t o gr o wi n g c hil dre n, as t he c o ns u m pti o n of t he e m pt y -cal orie pr o d uct ma y 
res ult i n t he dis place me nt of m ore n utriti o us f o o ds i n t he diet.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 5 of 1 2 2

C o u ncil of Me dical Researc h ( Nat i onal I nst itute of N utrit i on).  T h us , t he test gr o u p 
will be a d mi nistere d t he test pr o d uct ( f ortifie d malt base d f o o d ) w hile dietar y a d vice 
s hall be matc he d i n b ot h t he test a n d c o ntr ol gr o u ps wi t h res pect t o t he q ualit y, 
c o nte nt a n d d urati o n.  
T his pr o p ose d ra n d o mise d c o ntr olle d cli nical st u d y is i nte n de d t o test t he h y p ot hesis 
t hat a f ortifie d malt base d f o o d ma y i m pr o ve i m m u nity o ut c o m es i n 7 -1 0 y ear old 
sc h o ol a ge c hil dre n.
2. O B J E C TI V E S A N D E N D P OI N T S
O bjecti ves
E n d p oi nts
Pri m ar y

T o deter mi ne t he t otal n u m ber of 
ill da ys d ue t o GI a n d res pirat or y 
ill nesses i n part ici pa nts recei vi n g 
f ortifie d malt base d f o o d (test 
pr o d uct) wit h di et ar y c o u nselli n g 
i n c o mparis o n t o partici pa nt s 
recei vi n g o nl y dietar y  c o u nselli n g 
o ver a peri o d of ni ne m o nt hs.

T otal  n u m ber of ill da ys d ue t o GI
a n d res pirat or y ill nesses.
Sec o n d ar y

T o c o m pare t he f oll owi n g 
para m eters i n parti c i pa nts 
recei vi n g t he f ortifie d malt base d 
f oo d (test pr o d uct) al o n g wit h 
di et ar y c o u nselli n g t o partici pa nt s 
recei vi n g o nl y dietar y  c o u nselli n g 
o ver a peri o d of ni ne m o nt hs:
1.
Fre q ue nc y of GI a n d res pirat or y 
ill nesses.
1. N u m ber of e pis o des of GI a n d 
res pir at or y ill nesses.
2.
Se verit y of  GI a n d res pirat or y 
ill nesses.
2. Se verit y of  GI a n d res pirat or y 
ill nesses.
3.
Sc h o ol  a bse nteeis m d ue t o GI a n d 
res pir at or y ill nesses.
3. Sc h o ol a bse nteeis m d ue t o GI a n d 
res pir at or y ill nesses.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 6 of 1 2 2

4.
C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n b o d y  mass i n de x 
( B MI).
4. B MI at scree ni n g a n d e n d o f 
st u d y.
5.
C ha n ge fr o m baseli ne i n g ut 
i nte grit y/ he alt h as meas ure d b y 
Lact ul ose Ma n nit o l test.
5. G ut i nte grit y/ healt h as meas ure d 
b y Lact ul ose Ma n ni t ol test at 
baseli ne a n d e n d of st u d y .
6.
C ha n ge fr o m baseli ne i n g ut 
i nte grit y/ he alt h as meas ure d b y 
Uri nar y  Ne o pteri n test.
6. G ut i nte grit y/ healt h as meas ure d 
b y Uri nar y  Ne o pteri n test at baseli ne 
a n d e n d of st u d y.
7.
C ha n ge fr o m baseli ne i n m uc osal 
i m m u nity as meas ure d b y 
Sali var y  I m m u n o glo b uli n A (I g A) 
stat us.
7. Sali var y I m m u n o gl o b uli n A (I g A) 
stat us at  baseli ne a n d e n d of st u d y.
8.
C ha n ge fr o m baseli ne i n le vels of 
micr o n utrie nts Vi ta mi n A, B 6,
B 1 2, C, D ( 2 5-
h y dr o x yc h o lecalcifer ol), E, f olate, 
of  t he trace ele me nts sele ni u m, 
zi nc, c o p per, a n d ir o n as 
deter mi ne d b y bl o o d dra w a n d 
a nal ysis.
8. Le vels of micr o n utrie nts Vi ta mi n
A, B 6, B 1 2, C, D ( 2 5-
h y dr o x yc h o lecalcifer ol), E, f olat e, of 
t he trace ele me nts sele ni u m, zi nc, 
c o p per, a n d ir o n at baseli ne a n d e n d 
of  st u d y.
9.
C ha n ge fr o m baseli ne le vels o f 
ferritin, ser u m tra nsferri n rece pt or 
(s Tf R), C-reacti ve pr otei n ( C R P), 
a n d Al p ha 1 -acid gl yc o pr otei n 
( A G P) as deter mi ne d b y bl o o d 
dra w a n d a nal ysis.
9. Le vels of ferritin, ser u m 
tra nsferri n rece pt or (s Tf R), C-
reacti ve pr otei n ( C R P), a n d Al p ha 1-
acid gl yc o p r otei n ( A G P) at baseli ne 
a n d e n d of st u d y.
1 0. C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n dietar y di versit y 
sc ore, assesse d t hr o u g h 2 4-h o ur 
I n di vi d ual Dietar y Di versit y 
Sc ore (I D D S).
1 0. Di et ar y di versit y sc ore assesse d 
t hr o u g h 2 4-h o ur I D D S at  scree ni n g 
a n d e n d of st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 7 of 1 2 2

1 1. C ha n ge fr o m baseli ne ( meas ure d 
at scree ni n g) i n e ner g y, pr otei n, 
car b o h y drates a n d fat 
c o ns u m pti o n, assesse d t hr o u g h 
2 4- h o ur dietar y  recall s ur ve y.
1 1. I nta ke of e ner g y , pr otei n, 
car b o h y drate, a n d fat fr o m 2 4- h o ur 
di et ar y recall s ur ve y at scree ni n g a n d 
e n d of st u d y.
3. S T U D Y P L A N
3. 1. St u d y Desi g n
O ver all Desi g n
T his is a si n gle ce ntre, m ulti ple sites, o pe n la bel, t w o-ar m, parallel-gr o u p , stratifie d 
b y ge n der, matc he d p ai r cl uster ra n d o mise d, c o ntr olle d st u d y.
Visit 1 - Scree ni n g Visi t
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:

I nf or me d c o nse nt a n d asse nt

D e m o gra p hics

Me dical hist or y

C urre nt/c o nc o mita nt me dicati o n s

Ge neral p h ysical e xa mi nat i on

Vi t al si g ns

H b assess me nt usi n g Pr o n t o

A nt hr o p o m etric meas ure me nts ( h ei g ht a n d w eig ht)

I ncl usi on/e xcl usi o n cri teria e val uati o n

S u bject Eli gi bilit y

2 4 hr di etar y recall & di et ar y di versity s ur ve y

Pare ntal / L A R trai ni n g o n t he c o m plet i on of t he ‘ Sy m pt o m  Chec k L ist’
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 8 of 1 2 2


Di s pe nse bla n k Pare nt/ L A R Sy m pt o m C hec klist a n d Pr o d uct C o m pli a nce 
Re p ort F or m s
Visit 2 - B aseli ne Visit
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:

C urre nt/c o nc o mita nt me dicati o n s

C o nti n ue d e li gi bility cri t eria

S a m ple c ollect i on f or u ri nar y Ne o pteri n test & la ct ulose/ m a n nit ol test

S a m ple col lect i on f or a nal ysis of ser u m ferritin, s Tf R, C R P, A G P, s I g A & 
n utri tio nal b i oc he mistr y (f or micr o n utrie nts vita mi ns A, B 6, B 1 2, C , D, E, 
f olate, a n d of t he trace ele me nts sele ni u m, zi nc, c o p per, a n d ir o n)

A E m o ni t ori n g
Visit 3, 4, 5, 6, 7 , 8, 9, S P W R a n d Pr o d uct A d mi nistr ati o n Visits
T he f o ll owi n g assess me nts will be c o n d ucte d:

C urre nt/c o nc o mita nt me dicati o ns

C o nti n ue d eli gi bilit y cri t eria

Di et ar y c o u nselli n g will be a d mi nistere d t o all st u d y partici pa nts a n d t heir 
pare nts/ L A Rs.

Test pr o d uct will be a d mi n istere d t o all st u d y participa nts i n t he test gr o u p.

S P W R visits will be c o n d ucte d o n a wee kl y basis u nt il E n d of  St u d y Visit. 
Pare nt/ L A R s y m pt o m c hec klist & Pr o d uct C o m plia nce Re p ort F or ms will be 
c ollecte d a n d re vie we d.

A E m o ni t ori n g
Visit 1 0 - E n d of S t u d y Visit
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:

C urre nt/c o nc o mita nt me dicati o n
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 3 9 of 1 2 2


Ge neral p h ysical e xa mi nat i on

Vi t al si g ns

A nt hr o p o m etric meas ure me nts ( h ei g ht a n d w eig ht)

C o nti n ue d e li gi bility cri t eria

2 4 hr di etar y recall & dietar y di versity s ur ve y

S a m ple c ollect i on f or u ri nar y Ne o pteri n test & la ct ulose/ m a n nit ol test

S a m ple col lecti on f or a nal ysis of ser u m ferritin, s Tf R, C R P, A G P, s I g A & 
n utri tio nal b i oc he mistr y (f or micr o n utrie nts vita mi ns A, B 6, B 1 2, C , D, E, 
f olate, a n d of the trace ele me nts sele ni u m, zi nc, c o p per, a n d ir o n )

A E m o ni t ori n g

St u d y  c o mplet i on a n d m e dical si g n-of f
3. 2. S u bject Restricti o ns
L ifest yle/ Diet ar y
T he f o ll owi n g lifest yle / dietar y restrict i ons a p pl y t o st u d y partici pa nts, p ost e nr ol me nt 
aft er scree ni n g:

P arti cipa nt s s h o ul d re p ort t o t he st u d y site i n a 3-h o ur fast e d state o n t he da y of 
lact ulos e/ ma n nit ol test i n g. Parti ci pa nt s will be allo w e d t o ret ur n t o t heir re g ular 
di et 3 0 mi n utes after i n gest i on of t he lact ul ose /ma n nit o l test s oluti o n .

P arti cipa nt s m ust a bstai n fr om t he use of all ot her n utrit i onal s u p ple me nts.

P arti cipa nt s m ust a bstai n fr om use of all ot her healt h f o o d s u p ple me n ts.
Me dic ati o ns a n d Tre at me nts
T here are n o restricti ons wit h re gar ds t o me d icati on use a n d m e dical tr e at me nt .  As 
GI a n d res pirat or y  ill nesses are t he o utc o mes of i nterest, it is e x pecte d t hat s o me of 
t he partici pa nts ma y re q uire p har mac o l ogi cal ma na ge me nt of t heir s y m pt o ms or ot her 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 0 of 1 2 2

me dical treat me nt.   Use of i m m u n os u p pressi ve t her a p y e. g., oral c ortic oster oi ds or 
c he m ot hera p y d uri n g t he c o urse of  st u d y will be c o nsi dere d a pr ot oc ol vi o lati o n a n d 
will res ult i n t he re m o val o f t he s u bject fr o m t he efficac y a nal yses.
3. 3. T y pe a n d Pl a n ne d N u m ber of P artici p a nts
P arti ci pa nts will be recr uite d fr o m sc h o ols i n t he areas of t he st u d y ce ntre. St u d y staff 
ma y a d dress pare nts/ Le gall y A cce pta ble R e prese ntati ves ( L A Rs) i n par e nts-teac hers’
meet i n gs. It is n ot a ntici pate d t hat a n y a d vertisi n g s uc h as p osters, leaflets, ra di o, et c.
will be re q uire d t o ai d recr uit me nt. H o we ver, t hese met h o ds ma y be use d if re q uire d.
A p pr o xi matel y  1 3 0 0 parti ci pa nts will be scree ne d i n at least 4 sc h o ols ( wit h at least 2 
sc h o ols per st u d y gr o u p), t o ra n d o mise a p pr o xi matel y 9 2 4 parti ci pa nts t o e ns ure 6 4 6 
e val ua ble part ici pa nts c o m plete t he e ntire st u d y. T his will e ns ure at least 3 2 3 
e val ua ble part ici pa nts per stu d y gr o u p .
3. 4. St u d y Desi g n a n d D ose J ustific ati o n
R ati o n ale f or St u d y Desi g n
T his is a si n gle ce ntre, m ulti ple sites, o pe n la bel, t w o-ar m, parallel-gr o u p, stratifie d 
b y ge n der, matc he d pair cl uster ra n d o mise d, c o ntr olle d st u d y in c hil dre n a ge d 7 - 1 0 
years (incl usi ve) .
T here are se veral fact ors i ncl u di n g et hical, a d mi nistrati ve, c o m plia nce etc i n t he st u d y 
w hic h ma n date ra n d o mi sat i on at cl uster l e v e l rat her t ha n at i n di vi d ual le vel. Firstl y, 
t o ac hie ve d o u ble- bli n di n g, t he c hil dre n i n t he c o ntr ol gr o u p w o ul d ha ve t o be 
a d mi nistere d a n u nf ortifie d cal ori e free pr o d uct . H o we ver, it was deter mi ne d t hat it 
w o ul d be u net hical t o a d mi nister a n “e m pt y- calori e” pr o d uct t o gr o wi n g c hil dre n, as 
t he c o ns u m pt i on of t he e m pt y- calori e pr o d uct ma y res ul t i n t he dis place me nt of m ore 
n utri tio us f o o ds i n t he di et. T h us t he c o ntr ol gr o u p has bee n deci de d t o be n ot gi ve n 
a n y pr o d uct . Sec o n dl y, it w o ul d n ot be realistic & practical t o ra n d o mi se i n di vi d ual 
st u de nts i n a sc h o ol t o differe nt treat me nts. T h us a d mi nistrati n g t he i nter ve nt i on at 
clust er l e vel will i ncrease a d mi nistrati ve efficie nc y. T hir dl y, t here are hi g h c ha nces o f 
s hari n g of test pr o d uct (c o nta mi nat i on) fr o m u n- bli n de d partici pa nts i n test gr o u p t o 
u n- bli n de d partici pa nts i n c o ntr ol gr o u p if t he y bel o n g t o sa me cl uster (sc h o ol). 
C o nta mi nat i on of c o ntr ol  partici pa nts ca n ha ve t w o relate d effects i.e. it ca n re d uce 
t he p oint  esti mate of a n i nterve nti o n's effect i ve ness a n d c o nse q ue ntl y t he a p pare nt 
re d uctio n m a y lea d t o a t ype II err or — t hat is, i ncrease i n c ha nces of rejecti o n of a n 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 1 of 1 2 2

effect i ve i nter ve nt i on as i neffecti ve beca use t he o bser ve d effect size will neit her be 
statisticall y n or cli nicall y si g nifica nt. T h us wit h s uc h nat ure of i nter ve nt i on it its elf 
di ctates its a p plicati on at cl ust er l e vel.
Sc h o ol s wit h t he f oll owi n g c haracteri stics will be i n vite d t o partici pate i n t he st u d y :

L ocate d i n peri -ur ba n areas 

N o g o ver n me nt or s p o ns ore d micr o n utrie nt s u p ple me ntati o n sc he me r u n ni n g 
i n t he past 6 m o nt hs

M i xe d-ge n der e d ucati o n/c o -e d ucati o n s yste m of e d ucatio n

N o hist or y  of a n y o ut brea k or cl usteri n g of cases of i nfecti ous di seases i n last  
m o nt h
Matc hi n g creates c o m para ble gr o u ps at baseli ne a n d will pr o vi de ‘face vali dit y’ 
re gar di n g bala nce bet wee n treat me nt ar ms. T h us m atc hi n g t he clusters pri or t o 
ra n d om all ocati o n will i m pr o ve ca usal effect esti mati o n b y i m p r o vi n g i nter gr o u p 
h o m o ge neit y. Cl uster (sc h o ols) will be matc he d f or cl u ster size (i n c o nte xt t o t he 
n u m ber of c hil dre n i n 7- 1 0 y rs a ge gr o u p), s oci o ec o n o mic pr ofiles of st u de nts, a n d 
t ype of sc h o ol  (g o ver n me nt s u bsi dise d or pri vate ).
After o btai ni n g i nf or me d c o nse nt a n d asse nt, s c h o ol c hil dre n a ge d 7-1 0 y ears will be 
scree ne d t o i de ntif y eli gi bility base d o n t he pre -defi ne d i ncl usi o n a n d e xcl usi o n 
criteria.  T he c hil dre n will t he n be all ocate d t o t heir res pecti ve gr o u ps, base d o n t he 
ra n d om all ocati o n of t he sc h o ol t o w hic h t he y  belo n g.
N utri tio nal deficie nc y a n d t he res ult i n g i m m u nity o utc o m es ca n be i nfl ue nce d b y 
di et etic i nter ve nt i ons w hic h ai m t o i m pr o ve n utriti o nal i nta kes. T hese i nter ve nti ons 
pri maril y i ncl u de dietar y a d vice t o i m pr o ve t he n utriti o nal q uali t y of t he diet a n d oral 
n utri tio nal s u p ple me nt i nta ke.
T o test t he h y p ot hesis t hat M N s u p pl e me ntatio n ca n i m pr o ve i m m u n ol ogi cal/cli nical 
o utc o m e s, it is perti ne nt t hat t he t w o treat me nt gr o u ps are matc he d i n ter m s of  t heir
bac k gr o u n d diets . T h us t he test gr o u p will be a d mi nistere d t he test pr o d uct (f ortifie d 
malt base d f o o d ), w hile b ot h t he test a n d c o ntr ol gr o u ps will recei ve dietar y  a d vice 
(t he q ualit y, c o nte nt a n d d urati o n of  t he n utritio nal c o u nselli n g will be e q ui vale nt f or 
t he t w o gr o u ps).  Diet ar y c o u nselli n g is i nte n de d t o i m pr o ve k n o wle d ge, attit u de a n d 
practi ces as t he y relate t o n utritio n a n d di et, wit h t he o verall ai m of i m pr o vi n g t he 
q ualit y of  t he diet. Si nce t he i m pact of pare nt i n g o n diet is greatest i n t he earl y years, 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 2 of 1 2 2

a n d als o, as c hil dre n s pe n d si g nifica nt a m o u nts of ti me wi t h sc h o ol teac hers, b ot h 
pare nts a n d teac hers will als o be part of  t he di etar y c o u nselli n g.   Dietar y  c o u nseli n g 
will be base d o n t he Dietar y  G ui deli nes f or I n dia ns, esta blis he d b y t he I n dia n C o u ncil 
of  Me dical Researc h ( Natio nal  I nstit ut e of N utritio n).
Bac k gr o u n d diets a n d c ha n ges i n bac k gr o u n d diets ma y dist ort t he tr ue relat i ons hi p 
bet wee n t he i nter ve nt i on a n d t he o utc o me. T o eli mi nate s uc h p ossi ble c o nf o u n di n g, it 
is i m perati ve t hat q uality of  diet ar y int a kes is assesse d b ot h at start a n d e n d of st u d y . 
Si nce, q ualit y of  a diet is i m pacte d b y f oo d q ua nti t y a nd di versit y; b ot h t hese 
varia bles will be assesse d f or all st u d y partici pa nts. F or q ua ntitati ve assess me nt of 
f oo d c o ns u m pti o n, 2 4- h o ur dietar y  recall will be use d. T o u n dersta n d t he di versit y of 
f oo ds t hat t he c hil d is c o ns u mi n g, a 2 4 -h o ur I n di vi d ual Dietar y Di versit y Sc ore 
(I D D S) [ F A O g ui deli nes dietar y di versi t y, 2 0 1 1 ] will be use d.
C l uster sa m pli n g desi g n ma y i m pact effecti ve sa m ple size, w hic h ca n be miti gate d 
usi n g m o re n u m ber s of  cl usters. T h us, c o nsi deri n g feasi bility , at least 2 sc h o ols per
st u d y gr o u p will be selecte d .
T o c o ntr ol  for p ossi ble effects of ge n der, a bala nce d rati o of b o ys a n d girls i n t he test 
a n d c o ntr ol gr o u ps will be tar gete d. T he st u d y will be stratifie d b y ge n der t o recr uit a 
tar get rati o of 5 0 % girls a n d 5 0 % b oys, wit h a mi ni m u m o f 4 0 % of eit her ge n der a n d 
a ma xi m u m of 6 0 % of eit her ge n der.  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 3 of 1 2 2

T he st u d y  fl owc hart will be as f o ll ows:
Eli gi ble Sc h o ols 
i n st u d y area i n vite d t o 
parti ci pate
Sc h o ols n ot 
c o nse nti n g
Sc h o ols 
c o nse nti n g t o partici pate
Sc h o ols
matc he d t o f or m 
matc he d pairs
R A N D O M S E L E C TI O N
O F C L U S T E R S
Sc h o ols 
ra n d o ml y selecte d 
R A N D O M 
A L L O C A TI O N
O F C L U S T E R S
Sc h o ols all ocate d t o
T E S T G R O U P
Matc he d pair 
Sc h o ols 
all ocate d t o 
C O N T R O L 
G R O U P
A S S E S S M E N T O F 
E LI GI BI LI T Y
Eli gi ble Partici pa nts 
selecte d 
Eli gi ble 
Partici pa nts 
selecte d
I N T E R V E N TI O N
Test pr o d uct + 
Dietar y  c o u nseli n g
f or 9 m o nt hs
Dietar y  
c o u nseli n g
f or 9 m ont hs
L ost t o F oll o w u p
L ost t o F oll o w u p
A N A L Y SI S
Statistical a nal ysis t o 
c o m pare treat me nts 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 4 of 1 2 2

R ati o n ale f or P a r tici p a nts’ I ncl usi o n a n d Excl usi o n:
Wit h t he ass u m pt i on t hat t he st u d y p o p ulat i on is n or mall y distri b ute d f or W o rld 
Heal t h Or ga nisat i on ( W H O) h ei g ht -f or-a ge z- sc ores ( H A Z), refere nce p o p ulati o ns
wi t hi n -2 t o + 2 sta n dar d de viati o ns ( or z sc ore) re prese nt 9 5. 4 % p o p ulat i on. B ut f or 
t he st u d y p artici pa nts i n de vel o pi n g c o u ntries li ke I n dia, t he me d ia n f or t he H A Z i n 
c o mparis o n t o W H O gr o wt h sta n dar d s is t o war ds t he l o wer si de w hic h falls at 
a p pr o xi matel y -2 S D of t he W H O sta n dar d c ur ve at a ge 5 y ears [ Natio n al  Fa mil y 
H ealt h Sur ve y -3] [I n di a n Aca de m y of Pae diatrics Gr o wt h C harts C o m mittee, 2 0 1 5] . 
T h us a Z- sc ore bet wee n -3 t o -1 (rat her t ha n -2 t o + 2) w o ul d c o ver t he re prese ntati ve 
p o p ul at i on of de vel o pi n g c o u ntries li ke I n dia .
C hil dre n wit h a pri or or prese n t dia g n osis of a disease or c o n diti o n w hic h ma y affect 
i m m u ne f u ncti on or n utrit i onal stat us (e. g., t u berc ul osis, AI D S, diarr heal diseases) 
ca n n ot be i ncl u de d i n t he st u d y. Usa ge of me dicati o ns t hat ca n affect n utriti onal stat us 
or i m m u ne f u nct i on ( e. g., im m u n os u p pressi ve t her a pies, s uc h as or al  c ortic oster oids 
or c he m ot hera p y ) als o will res ult i n st u d y ineli gi bilit y.
R ati o n ale f or D ose
C hil dre n i n sc h o ols t hat ha ve bee n ra n d omise d t o recei ve t he f ortifie d malt base d 
f oo d will be a d mi nistere d t w o d oses of t he test pr o d uct dail y f or 9 mo nt hs. Eac h d ose 
will be pre pare d b y rec o nst ituti n g a sac het of t he f ortifie d malt base d f o o d ( 2 7 gra ms 
p o w der ) wit h 15 0 m L of  l u ke war m water. T h us, per da y , partici pa nts i n sc h o ols t hat 
ha ve bee n ra n d o mise d t o recei ve t he f ortifie d malt base d f o o d will c o ns u me a t otal of 
a p pr o xi matel y 3 0 0 m L of t he pr o d uct eac h da y. T he t otal dail y d ose will res ult i n t he 
i nta ke of micr o n utrie nts at le vels wit hi n R ec o m me n de d D ietar y All o wa nces ( R D As), 
as esta blis he d b y t he W H O a n d als o bel o w t h e u p per t olera ble le vels of t he res pect i ve 
micr o n utrie nt s, as esta blis he d b y F o o d a n d N utrit i o n B oar d, I nstitut e of Me dici ne, 
Nati o nal Aca de mies . 
T o pre ve nt st o mac h f ull ness as a deterre nt a gai nst c o m plia nce, t he i nter val bet wee n 
t he t w o d oses will be ma x i mise d d uri n g all sc h o ol  da ys. St u d y staff will ma ke eff orts 
t o a d mi nister o ne d ose as s o o n as t he partici pa nts e nter t he sc h o ol a n d t he sec o n d 
d ose will be pr o vi de d j ust pri or t o sc h o ol dis missal. At h o me, eac h da y o ne d ose will 
be a d mi nistere d prefera bl y i n t he mor ni n g a n d t he sec o n d d ose will be a d mi nistere d 
prefera bl y i n e ve ni n g, b y  pare nts/ L A Rs.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 5 of 1 2 2

R ati o n ale f or Sc he d ule of Diet ar y C o u nselli n g Sessi o ns 
Di et ar y c o u nselli n g s hall be i m parte d i n t w o p hases. I n first p hase, c o m plete c o nte nts 
of  diet ar y e d ucatio n a n d a d vices will be deli vere d i n t w o sessi o ns i n first t w o wee ks 
of  st u d y p erio d. W hile sec o n d p hase, will mai nl y  d e al wit h t he fol l ow u p of  c o nte nts 
deli vere d i n sessi o n 1 a n d 2. F o ll ow u p sessi o ns will be c o n d ucte d t o rei nf orce t he 
c o nte nts deli vered a n d als o t o s ol ve a n d sat isf y a n y q u er y/ pr o ble m arise n w hile 
f oll owi n g t he dietar y  practices. A t otal of fi ve f o ll ow u p sessi o ns will be c o n d ucte d 
p ost c o m plet i on of t w o c o nte nt deli ver y  sessio ns.
A mi ni m u m of 4 wee ks of ga p bet wee n c o nsec ut i ve c o nte nt deli ver y sessi o n a n d 
f oll ow u p sessi o n (i .e. bet wee n sessi on 2 a n d 3); a n d t w o c o nsec ut i ve f oll ow u p 
di et ar y c o u nselli n g sessi ons (i.e. bet wee n sessi o n 2, 3, 4, 5, 6 a n d 7) m ust be 
mai ntai ne d.  A ga p of 4 wee ks will pr o vi de a de q uate ti me t o partici pa nts/
pa re nts/ L A Rs t o practice t he teac hi n g of dietar y c o u nselli n g, t h us e n ha nci n g 
efficie nc y a nd efficac y  of dietar y c o u nselli n g.
I n vie w of l on g st u d y  p erio d, i t is e x pecte d t hat sc h o ol aca de mic e xa mi nati ons dates 
ma y clas h wit h t he sc he d ule d dietar y  c o u nseli n g sessi ons. T h us, it will n ot be et hical 
t o e x pect eit her partici pa nts or t heir pare nts/ L A Rs t o atte n d dietar y c o u nseli n g 
sessi o ns d uri n g partici pa nt’s sc h o ol e xa ms. I n case, if a n y dietar y c o u nseli n g sessi on 
is n ot c o n d ucte d d ue t o reas o ns s uc h as sc h o ol e x a ms, lo n g sc h o ol  hol i da ys etc, t he 
ne xt sessi o n f or diet ar y c o u nseli n g will be p ost p o ne d a n d c o n d ucte d as s o o n as 
parti ci pa nt is a vaila ble i n sc h o ol a n d e xa ms are fi nis he d.
4. S E L E C TI O N O F S T U D Y P O P U L A TI O N A N D 
WI T H D R A W A L C RI T E RI A
S pecific i nf or mati o n re gar di n g war ni n gs, preca uti o ns, c o n trai n dicatio ns, a d verse 
e ve nts, a n d ot her perti ne nt i nf or mat i on o n t he G S K i n vest i gati onal pr o d uct or ot her 
st u d y tr e at me nt t hat ma y i m pact s u bject eli gi bility is pr o vi de d i n t he safety state me nt.
De viat i ons fr o m  incl usi o n a n d e xcl usi o n cri t eria are n ot all owe d beca use t he y  ca n 
p ote nti all y je o par d ise t he scie ntific i nte grit y of  t he st u d y, re g ulat or y acce pta bility or 
s u bject safet y. T heref ore, a d here nce t o t he criteria as s pecifie d i n t he pr ot oc ol is 
esse nt ial.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 6 of 1 2 2

4. 1. I ncl usi o n Criteri a
A s u bject will be eli gi ble f or i ncl usi o n i n t his st u d y o nl y if all of t h e fol l owi n g criteria 
are esta blis he d :
1.
C o nse nt a n d Asse nt
D e m o nstrates u n dersta n di n g of t he st u d y  a n d willi n g ness t o partici pate as 
e vi de nce d b y t he pare nt ’s a n d/ or L A R ’s v o l unt ar y writte n i nf or me d c o nse nt as 
well as writte n asse nt b y t he c hil d a n d has recei ve d a si g ne d a n d date d c o p y  of 
t he i nf or me d c o nse nt f or m as well as t he asse nt f or m.
2.
A ge a n d Ge n der
B o ys a n d girls a ge d bet wee n 7 -1 0 y rs, i nclusi ve
3.
C o m plia nce
C hil d a n d pare nt/ L A R u n dersta n d a n d are willi n g, a ble a n d li kel y t o c o m pl y 
wi t h all st u d y pr oce d ures a n d restricti ons.
4.
Ge neral Healt h 
G o o d ge neral a n d me ntal healt h wi t h, i n t he o pi ni on of t he i n vest i gat or or 
me dicall y q ualifie d desi g nee : 
a) N o cli nicall y si g nifica nt a n d rele va nt a b n or malit ies i n me dical hist or y or 
u p o n p h ysical e xa mi nat i on.
b) A bse nce of  a n y c o n ditio n t hat c o ul d affect t h e c hil d’s safety or well bei n g or 
t heir a bilit y t o u n dersta n d a n d f oll o w st u d y pr oce d ures a n d re q uire me nts.
5. Parti cipa nt s wit h H A Z of  ≥- 3 t o ≤- 1.
4. 2. E xcl usi o n Criteri a
1.
C hil dre n i n Care ( Ci C): A c hil d w h o has bee n place d u n der t he c o ntr ol or 
pr otecti o n o f a n a ge nc y, or ga nisati on, i nst ituti o n or e nti t y b y t he c o urts, t he 
g o ver n me nt or a g o ver n me nt b o d y , acti n g i n acc or da nce wit h p o wers 
c o nferre d o n t he m b y la w or re g ulat i on. T he defi niti o n of  a Ci C ca n i ncl u de a 
c hil d care d f or b y foster pare nts or li vi n g i n a care h ome or i nst ituti o n, 
pr o vi de d t hat t he arra n ge me nt falls wit hi n t he defi nit i on a b o ve. T he defi nit i on 
of  a CiC d oes n ot i ncl u de a c hil d w h o is a d o pte d or has a n a p p o i nte d le gal 
g uar di a n.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 7 of 1 2 2

2.
Aller g y/I nt o lera nce
K n o w n or s us pecte d i nt olera nce or h y p ers e nsitivi t y t o t he st u d y mat erials ( or
clos el y  relate d c o mp o u n ds) or a n y  of t heir state d i n gre die nts.
3.
I n dicati on t hat c hil d is li kel y t o mo ve o ut of ge o gra p hical ra n ge of t he st u d y  
wi t hi n t he peri o d of st u d y int er ve nt i on a n d act i vities, t h us hi n deri n g t he 
chil d’s c o m p lia nce t o st u d y acti vities.
4.
Cli nical St u d y / E x peri me ntal Me dicati on
a)
P arti cip ati o n i n a n ot her cli nical st u d y  or receipt of  a n i n vesti gati onal dr u g 
wi t hi n 3 0 da ys o f t he scree ni n g visit.
b)
P arti cip ati o n i n a n y  nutri tio nal st u d y  or di dact ic n utriti o n e d ucat i on i n t he 
last 6 m o nt hs of t he scree ni n g visit.
c)
Pre vi o us partici pat i on i n t his st u d y.
5.
C hil d wi t h se vere a nae mia ( He mo gl o bi n < 8 g/ d L).
6.
C hil dre n wi t h hist or y of use of i m m u n os u p pressi ve t hera p y e. g., oral 
c ortic oster oids or c he m ot h era p y i n past si x m on t hs prior t o t he scree ni n g visit.
7.
C urre nt or rele va nt hist or y  of a n y s erio us, se vere or u nsta ble p h ysical or 
ps yc hiatric ill ness or a n y  me dical dis or der t hat w o ul d ma ke t he partici pa nt
u nli kel y  t o full y c o m p lete t he st u d y or a n y c o n ditio n t hat prese nts u n d ue ris k 
fr om t he test pr o d uct or pr oce d ures, o n t he discret i o n of st u d y p h ysicia n .
8.
Rece nt hist or y  [ 2 mo nt hs] of seri o us i nfect i ons, i nj uri es a n d/ or s ur geries i n 
t he o pini o n of t he i n vest i gat or.
9.
C hil dre n c o ns u mi n g n utrit i onal s u p ple me nts a n d/ or healt h f o o d dri n ks o n a 
re g ular basis ( ≥3 ti mes a wee k) i n last 3 m o nt hs.
1 0. Pers o n nel
a. C hil d bel o n gi n g t o a n e m pl o yee of t he s p o ns or or t he st u d y  sit e or me m bers 
of  t h eir i m me diate fa mil y.
b. Si bli n g o f a c hil d alrea d y e nr o lle d i n t he st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 8 of 1 2 2

4. 3. Scree ni n g/ B aseli ne F ail ures
Scree n fail ures are defi ne d as part ici pa nts w h o c o nse nt t o parti ci pate i n t he st u d y but 
ne ver s u bse q ue nt l y recei ve st u d y int er ve nt i on .  I n or der t o e ns ure tra ns pare nt 
re p orti n g of scree n fail ure parti ci pa nts, a mi ni mal set of scree n fail ure i nf or mati o n is 
re q uire d i ncl u di n g De m o gra p h y, Scree n Fail ure details, Eli gi bility Cri t eria, a n d a n y 
S eri o us A d verse E ve nts. Re -scree ni n g of part ici pa nts will n ot be all o we d i n t his 
st u d y.
4. 4. Wit h dr a w al/ St o p pi n g Criteri a
A s u bject m a y wit hdra w fr o m  t he st u d y at a n y time at his/ her o w n re q uest, or ma y be 
wi t hdra w n at a n y ti me at t he discreti o n of t he i n vesti gat or f or safet y,  be ha vi oral or 
a d mi nistrati ve reas o ns. If a s u bject wit h dra ws or is wit h dra w n fr o m t he st u d y, all 
h u ma n bi o l ogi c al sa m ples c ollecte d bef ore t he y left will be a nal yse d a n d re p orte d 
u nless t he s u bject re q uests ot her wise. A parti ci pa nt ma y re q uest f or t heir h u ma n 
bi o l ogical  sa m ples t o be destr o ye d. I n t hese cases, t he i n vest i gat or m ust d oc u me nt 
t his i n t he site st u d y rec or ds a n d t he sa m ples s h o ul d n ot be use d f or a n y furt her 
researc h.
If t he reas o n f or re m o val of a s u bject fr o m t he st u d y is a n A E or a n a b n or mal 
la b orat or y test res ult, t he pri nci pal s pecific e ve nt or test will be rec or de d o n t he 
ele ctr o nic case re p ort f or m ( C R F).  If a s u bject is wit h dra w n fr o m t he st u d y  beca use 
of  a pr o d uct li miti n g A E, t h or o u g h eff orts s h o ul d be clearl y ma de t o d oc u me nt t he 
o utc o m e. A n y A Es o n g oi n g at t he fi nal visit will be f oll owe d u p u nt il res ol ve d, t he 
c o n ditio n sta bil ises, is ot her wise e x plai ne d, or t he s u bject is l ost t o f oll ow- u p.
T he f o ll owi n g acti o ns m ust be ta ke n i n relati o n t o a s u bject w h o fails t o atte n d t he 
cli nic f or a re q uire d st u d y visit:

T h e sit e must atte m pt t o c o ntact t he s u bject a n d re -sc he d ule t he misse d visit as 
s o o n as p ossi ble. 

T he site m ust c o u nsel t he s u bject o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule a n d ascertai n w het her or n ot t he s u bject wis hes t o 
a n d/ or s h o uld c o nti n ue i n t he st u d y . 

I n cases w here t he s u bject is dee me d ‘l ost t o f oll ow u p’, t he i n vesti gat or or 
desi g nee m ust ma ke e ver y eff ort t o re gai n c o ntact wit h t h e s u bject ( w here 
p ossi ble, at least 2 tele p h o ne calls). T he c o ntact atte m pt s h o ul d be 
d oc u m e nted i n t he s u bject’s rec or d. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 4 9 of 1 2 2


S h o ul d t he s u bject c o nti n ue t o be u nreac ha ble, o nl y  t he n will he/s he be 
c o nsi dere d t o ha ve wit h dra w n fr o m t he st u d y wit h a pri mar y reas o n of “ L ost 
t o F oll o w-u p”.
4. 5. S u bject Re pl ace me nt
P arti cipa nt w h o wit h dra w s fr om t he st u d y p ost-ra n d o misat i on will n ot be re place d.
4. 6. S u bject a n d St u d y C o m pleti o n
A c o m p lete d s u bject is o ne w h o has c om p lete d all p hases of  t he st u d y incl u di n g t he 
f oll ow- u p visit.
T he e n d o f t he st u d y is defi ne d as t he date of t he last s u bject’s last visit.
5 . P R O D U CT I N F O R M A TI O N
5 . 1. Stu d y Pr o d uct
T he f o ll owi n g st u d y  pr o d uct will be s u p plie d b y t he Cli nical S u p plies De part me nt, 
G S K C H:
Test Pr o d uct
Pr o d uct N a me 
F ortifie d malt base d f o o d
Pr o d uct F or m ul ati o n C o de
 
D ose
2 7 gra ms
R o ute of A d mi nistr ati o n
Oral
D osi n g I nstr u cti o ns
2 7 gra ms p o w der ma de u p i n 1 5 0 m L 
l u ke war m water, a d mi nistere d t wice dail y
Ot her ite ms t o be s u p plie d b y t he Cli nical S u p plies De part me nt, G S K C H:
N a me of Ite m
P ur p ose
T u m blers
T o assi st wit h t he a d ditio n of  t he c orrect 
v o l ume of l u ke war m water d u ri n g t he 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 0 of 1 2 2
C CI

pre parati o n of  dail y test d ose a n d t o assist 
wi t h t he assess me nt of c o m plia nce 
( v ol ume re m ai ni n g)
Sti rrers
T o assi st mi xi n g duri n g t he pre parati o n 
of  dail y test d ose
5 . 2. D ose Sc he d ule
P arti cipa nts will be a d mi nistere d t w o d oses of t he dri n k (a p pr o x 1 5 0 m L eac h) dail y 
f or 9 m o nt hs . T o ma xi mise t he i nter val bet wee n t he t w o d oses, d uri n g all sc h o ol da ys 
st u d y staff will ma ke eff orts t o a d mi nister o ne d ose as s o o n as t he partici pa nts e nter 
t he sc h o ol a n d t he sec o n d d ose will be pr o vi de d j ust pri or t o sc h o ol di s missal. At  
h o me, eac h da y o ne d ose will be a d mi nistere d prefera bl y  i n t he mor ni n g a n d t he 
sec o n d d ose will be a d mi nistere d pr ef era bl y i n e ve ni n g, b y pare nts/ L A Rs.
5. 3 . D ose A d mi nistr ati o n
T he gra d uate d t u m bler will be fille d wit h l u ke-war m  w ater u p t o t he 1 5 0 mL mar k. 
T he e nt ire c o nte nt s of  o ne sac het will be gra d uall y e mpt ie d i n t he water fille d t u m bler 
wi t h int er mitte nt stirri n g t o a v oid f or m at i on of l u m ps. T he rec o nstit ute d test pr o d uct
will be pr o vi de d t o t he partici pa nts i m me diatel y f o r oral c o ns u m pt i on.
O n all sc h o ol da ys, t w o test pr o d uct d oses (eac h d ose of 2 7 g i n 1 5 0 m L l u ke war m 
water) will be pr o vi de d t o t he partici pa nts at sc h o ols, u n der t he s u per visi o n of trai ne d 
researc h pers o n nel. At sc h o ols, t he test pr o d uct will be rec o nstit ute d b y site staff 
usi n g b ottl e d water. T he partici pa nts will be gi ve n c o u nte d n u m ber of si n gle ser ve 
sac hets ( 2 7 gra ms eac h) f or c o ns u m pt i on o ver wee ke n ds a n d d uri n g ot her sc h o ol 
h o li da ys a n d sc h o ol a bse nteeis m. T he partici pa nt’s pare nts/ L A Rs will be i nf or me d 
d u rin g t he c o nse nt i n g pr ocess o n h o w t o pre pare t he pr o d uct i n l u ke war m water 
( b oile d water will be rec om me n de d).
5 . 4. D ose M o dific ati o n
N o m o dif icati on t o t he d osi n g re gi me n will be all o we d. A n y variat i on fr o m t he 
d osi n g re gi me n will be re p orte d t o t he st u d y site pers o n nel a n d details will be e ntere d 
o n t he test pr o d uct a d mi nistrati o n l o g a n d t he n e ntere d i nt o t he C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 1 of 1 2 2

5 . 5. Pr o d uct C o m pli a nce
F or d oses a d mi nistere d at sc h o ol, st u d y-pers o n nel will s u per vise a n d e ns ure c o m plete
c o ns u m pti o n of test pr o d ucts. Ra n d o m h ome vis its will be ma de b y site staff t o 
e ns ure c o mplia nce of pr o d uct c o ns u m pt i on at h o m e. Details o f dail y pr o d uct 
c o ns u m pti o n (in cl u di n g wee ke n ds, sc h o ol  h oli da ys a n d sc h o ol a bse nteeis m) will be 
e ntere d i n t he C R F.
I n t he u nli kel y e ve nt t hat t he test pr o d uct is i nc om pletel y c o ns u me d ( d ue t o acci de ntal
s pilla ge, f or i nsta nce) or n ot a d mi nistere d, t his will als o be n ote d i n t he C R F al o n g 
wi t h t he pr o d uct v ol u me t hat was n ot c o ns u me d (i n case of i nc o m p lete c o ns u m pti on). 
I n case t his ha p pe ns at h o me, pare nts/ L A R will nee d t o e nter details i n t he Pr o d uct 
C o m plia nce Re p ort ( A p pe n di x 4 ). Site staff will dis pe nse as ma n y bla n k re p orts as
a p pr o priat e for rec or di n g details. Eac h re p ort will be n u m bere d i n a n asce n di n g or der 
(f or eac h partici pa nt) a n d rec or ds s h o ul d be mai ntai ne d t o trac k t he t otal n u m ber of 
re p orts dis pe nse d a n d c o llecte d. Partici pa nt will be c o nsi dere d as n o n-c o mplia nt if t he 
parti c i pa nt c o ns u mes less t ha n 7 0 % of  t he t otal a m o u nt of rec o m me n de d (f or t he 
e nt ire st u d y d urati o n) d ose.
5. 6 . Prec a uti o ns
N o s pecial preca ut i ons are necessar y  pr o vi de d t he test pr o d uct is use d i n acc or da nce 
wi t h t he pr ot oc ol a n d t he usa ge i nstr ucti o ns.
5. 7. O ver d ose
A n o ver d ose is a deli berate or i na d verte nt a d mi nistrati o n of a pr o d uct at a d ose hi g her 
t ha n s pecifie d i n t he pr ot oc ol.
O ver d ose is n ot li kel y t o occ ur i n t his st u d y .  Li mit ed q ua nt ities of t he pr o d uct will be 
s u p plie d, a n d cl osel y mo ni t or e d b y t he sit e for eac h s u bject.
O ver d ose per se is n ot a n A E.  H o we ver, a n y  cli nical se q uelae of a n o ver d ose s h o ul d 
be re p orte d as a n A E (a n d seri o us a d verse e ve nt ( S A E), if a p pr o priate).  F or 
re p orti n g, f oll ow t he A E a n d S A E re p or ti n g i nstr ucti o ns.
5. 8 . Resc ue T her a p y
N o resc ue t hera p y  is re q uire d i n t his st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 2 of 1 2 2

5. 9 . Pr o d uct Assi g n me nt
P rior t o t he start of t he st u d y , sc h o ols wi t hi n matc he d pairs will be assi g ne d t o test
a n d c o ntr ol gr o u p i n acc or da nce wit h t he ra n d o mi satio n sc he d ule ge ne rate d b y t he 
Bi ost ati stics De partme nt , G S K C H, usi n g vali date d i nter nal s oftware.
5. 9. 1 R a n d o mi sati o n
A u ni q ue scree ni n g n u m ber will i de nt if y eac h partici pa nt scree ne d f or st u d y  
parti ci pat i on.  At  eac h sc h o ol, scree ni n g n u m bers will be assi g ne d i n asce n di n g 
n u merical or der as eac h parti ci pa nt’s pare nt/ L A R si g ns t heir c o nse nt f or m. 
T his st u d y  will foll o w cl uster ra n d o misat i on w here i n sc h o ol s will be ter me d as 
clusters a n d t he n matc he d pairs will be f or me d o n t he basis o f crit eria defi ne d i n 
Secti o n 6. 1. As sc h o ol s are deter mi ne d t o be f ull y eli gi ble a n d mat c he d pair s are 
f or me d, sc h o ols wit hi n t he matc he d pairs will be ra n d o mise d acc or di n g t o t he 
r an d o misat i on sc he d ule pr o vi de d t o t he st u d y  ce ntres. Eac h m atc he d pair will be 
assi g ne d a ra n d o misati o n n u m ber i n asce n di n g n u merical or der as eac h matc he d pair 
is f or me d.
O nce 6 0 % of partici pa nts fr o m a n y ge n der ha ve bee n e nr olle d wit hi n a st u d y gr o u p, 
recr uit me nt i nt o t hat ge n der will st o p t o e ns ure t hat t here is a ma xi m u m 6 0 % of eit her 
male or fe male. Re mai ni n g 4 0 % of partici pa nts will be recr uite d fr o m ot her ge n der.
T he ra n d o misat i on sc he d ul e will be pr o vide d b y t he Bi ostatistics De part me nt , 
G S K C H.
5. 9. 2 Bli n di n g
T his is a n o pe n -la bel st u d y; he nce t here will be n o re q uire me nt f or bli n di n g of  st u d y 
pers o n nel at site a n d s p o ns or/ C R O . 
T he st u d y  ce ntre will recei ve a ra n d o misati o n sc he d ule t o be use d b y t he ce ntre f or 
ra n d omisat i on of  matc he d-p ai r cl usters.  T his sc he d ule will ha ve a ra n d omisati o n 
n u m ber f or a matc he d pair of  cl usters f oll owe d b y t he st u d y  gr o u p (test/c o ntr ol) f or 
i nter ve nt i on wi t hi n clust ers .
5. 9. 3 C o de Bre a ks
Si nce t he i n vesti gat or is u n -bli n de d t o t he treat me nt t here will be n o re q uire me nt of 
brea ki n g t he c o de i n t he st u d y  b y/for i n vest i gat or.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 3 of 1 2 2

5. 1 0 . P ac k a gi n g a n d L a belli n g
T he test pr o d uct will be s u p plie d i n plai n w hite sac hets wit h a st u d y la bel affi xe d t o 
eac h sac het.  Eac h s u bject will recei ve a s u bject cart o n wit h s ufficie nt sac hets t o 
c o ver t he d urati o n of t he i nter ve nti o n p eri o d.
T he c o nte nts of t he la bel will be i n acc or da nce wit h all a p plica ble re g ulat or y 
re q uire me nts a n d will be t he res p o nsi bilit y of  t he Cli nical S u p plies De part me nt, 
G S K C H.
All s u n dr y ite ms will be s u p plie d i n t heir c o m mercial pac ka gi n g f or use t hr o u g h o ut 
t he st u d y as re q uire d.
Care s h o ul d be ta ke n wit h t he s u p plie d pr o d ucts a n d t heir la bels s o t hat t he y  are 
ma i ntai ne d i n g o o d c o n ditio n.  It i s i m p orta nt t hat all la bels re mai n i ntact a n d le gi ble 
f or t he d uratio n of  t he st u d y. Parti ci pa nts s h o uld be i nstr ucte d t o n ot re m o ve or deface 
a n y part of t he st u d y la bel.
5. 1 0 . 1. Acc o u nt a bilit y of Pr o d uct
All pr o d ucts s u p plie d are f or use o nl y i n t his cli nical st u d y  a n d s h o uld n ot be use d f or 
a n y ot her p ur p ose.
T he i n vest i gat or or desi g nee will mai ntai n a f ull rec or d of test pr o d uct acc o u nta bilit y.  
A Pr o d uct Dis pe nsi n g L o g m ust be ke pt c urre nt a n d will c o ntai n t he f oll o wi n g 
i nf or mat i on:

T he i de nt ificati on of t he s u bject t o w h o m t he test pr o d uct was dis pe nse d.

T he dates a n d q ua nt ity of  t he test pr o d uct dis pe nse d t o t he s u bject.

T he dates a n d q ua nt ity of  t he test pr o d uct/e m pt y sac hets ret ur ne d b y t he 
s u bject (if a p plica ble).
T he i n ve nt or y  must be a vaila ble f or i ns pect i on b y t he st u d y  mo ni t or d uri n g t he st u d y. 
D uri n g a n d a t t he e n d of t he st u d y, test pr o d uct s u p plies will be verifie d b y t he 
m o nit or.  Test pr o d uct s u p plies will t he n be eit her c ollecte d b y t he st u d y mo ni t or or 
ret ur ne d b y t he i n vesti gat or or desi g nee t o t he G S K C H Cli nical S u p plies De part me nt 
or desi g nate d ve n d or.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 4 of 1 2 2

5. 1 0 . 2. St or a ge of Pr o d uct
St u d y  pr o d uct s u p plies m ust be st ore d i n c o m plia nce wit h t he la bel re q uire me nts i n a 
sec ure place wit h li mite d or c o ntr olle d access.
6 . S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
T his secti on lists t he pr oce d ures a n d para meters of eac h pla n ne d st u d y assess me nt.  
T he e xact ti mi n g of eac h assess me nt is liste d i n t he Sc he d ule of E ve nts sect i on.
A d here nce t o t he st u d y  desi g n re q uire me nts, i ncl u di n g all assess me nts a n d 
pr oce d ures are esse nti al a n d re q uir e d for st u d y  c o n d uct.
6. 1. M atc he d P air F or m ati o n
Eac h sc h o ol will be dee me d as a cl uster. Sc h o ols wit h f o ll owi n g c haracterist ics will 
be i n vite d t o partici pate i n t he st u d y:

L ocate d i n peri -ur ba n areas 

N o g o ver n me nt or s p o ns ore d micr o n utrie n t s u p ple me ntatio n sc he me r u n ni n g 
i n past 6 m o nt hs

M i xe d-ge n der e d ucati o n/c o -e d ucati o n s yste m of  e d ucatio n

N o hist or y  of a n y o ut brea k or cl usteri n g of cases of i nfect i ous di seases i n last 
m o nt h
S c h o ols w hic h a gree t o partici pate will be selecte d a n d will be s u bse q ue ntl y matc he d 
f or cluster si ze (in c o nte xt t o t he n u m ber of c hil dre n i n 7 -1 0 y rs a ge gr o u p), 
s o cioec o n o mic pr ofiles of st u de nts, a n d t y pe of sc h o ol; g o ver n me nt s u bsi di se d or 
pri vate .
6 . 2. I nf or me d C o nse nt a n d Asse nt
T he i n vest i gat or, or desi g nee, m ust o btai n writte n (si g ne d a n d date d) i nf or me d 
c o nse nt fr o m eac h part ici pa nt’s pare nt or L A R a n d/ or i m partial wit ness, parti ci pat i n g 
i n t his st u d y after a de q uate e x pla n atio n of  t he ai ms, met h o ds, o bjecti ves, a n d 
p ote nti al hazar ds of t he st u d y.  T he i n vesti gat or, or desi g nee, m ust als o e x plai n t o t he 
parti ci pa nt’s pare nts or partici pa nt’s L A R t hat t he y are c o m pletel y free t o ref use f or 
t heir c hil d t o e nter t he st u d y or t o wit hdra w fr o m  it at a n y time.  T he y  will als o be 
n otifie d t hat t he y  ar e free t o wit hdra w c o nse nt f or a c ollecte d bi o l ogi c al sa m ple t o be 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 5 of 1 2 2

use d after t he c ollect i on. T he i n vesti gat or ma y  c o ntact t he pare nts/ L A Rs d uri n g 
pare nts -teac hers meeti n g t o i nf or m t he m a b o ut t he st u d y. C o nse nt will be o btai ne d 
fr om i ntereste d pare nts/ L A Rs o n t he sa me da y of pare nts -teac hers meeti n g if p ossi ble 
or t he y  will be pr o vide d wi t h alter nate a p p oi ntme nt dates t o c o me f or c o nse nt i n g a n d 
scree ni n g acti vities.
O nce t he pare ntal or L A R c o nse nt pr ocess is o ver, se parate asse nt will be o btai ne d 
fr om t he pr os pective st u d y  p artici pa nts, w h ose pare nts/ L A Rs ha ve c o nse nte d. If 
parti ci pa nts d o n ot give asse nt des pite pare ntal/ L A R c o nse nt, t he y  will be e xcl u de d 
fr om t he st u d y. Asse nt will al wa ys be o btai ne d o nl y after c o nse nt is o btai ne d fr o m 
Pare nts/ L A R .
A p pr o priate f or ms f or d oc u me nti n g a writte n c o nse nt a n d asse nt will be pr o vi de d b y 
t he i n vest i gat or or b y G S K C H or b y  C R O.  T he i n vestigat or, or desi g nee, s h o ul d si g n 
a n d date t he c o nse nt a n d asse nt f or m t o c o nfirm t hat t he pr ocess was c o m plete d 
c orrectl y.  
A c o p y  of t he sig ne d a n d date d c o nse nt a n d asse nt f or ms will be pr o vi de d t o t he 
parti ci pa nt’s pare nts / L A Rs al o n g wit h a n y ot her writte n i nf or mat i on a n d t he y  will 
be i nstr ucte d t o retai n t hese d oc u me nts. 
O bta i ni n g i nf or me d c o nse nt a n d asse nt a n d perf or mi n g scree ni n g acti vities ca n be o n 
differe nt dates b ut i nf or m e d c o nse nt a n d asse nt will be o btai ne d pri or t o perf or mi n g 
a n d a p pl yi ng a n y scree ni n g crit eria or pr oce d ures. Scree ni n g act i vities s h o uld be 
wi t hi n 6 0 da ys o f o btai ni n g c o nse nt a n d asse nt . A partici pa nt will be c o nsi dere d t o be 
e nr o lle d i n t he st u d y after o btai ni n g c o nse nt a n d asse nt, he/s he has bee n f o u n d 
eli gi ble f or st u d y basis all st u d y scree ni n g criteria a n d pr oce d ures.
If, d uri n g a partici pa nt’s partici pat i on i n t he st u d y, a n y ne w i nf or mati o n bec ome s 
a vaila ble t hat ma y affect t he partici pa nt’ s/ pare nts or L A Rs willi n g ness t o partici pate 
i n t he st u d y, eac h o n g oi n g partici pa nt’s pare nt or L A R s h o ul d recei ve a c o p y of t his 
ne w i nf or mat i on a n d be re -c o nse nte d i nt o t he st u d y. R e -asse nt will als o be s o u g ht 
fr om parti ci pa nts Parti ci pa nt’s pare nts or L A R s h o ul d be pr o vi de d wit h a c o p y of t he 
sig ne d a n d date d a m e n de d c o nse nt a n d asse nt f or m.
6. 3 . De m o gr a p hics
T he f o ll owi n g de m o gra p hic para meters will be ca pt ure d b y  t he I n vestigat or or 
desi g nee a n d rec or de d o n t he C R F: year of birt h, ge n der a n d race.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 6 of 1 2 2

6. 4 . Me dic al Hist or y a n d C o nc o mit a nt Me dic ati o n
F or eac h partici pa nt, t he me dical hist or y  will be ta ke n a n d re vie we d b y t he
I n vesti gat or or me dicall y q ualifie d desi g nee. Details of a n y rele va nt me dical or
s ur gical hist or y (i n t he last si x mo nt hs), i ncl u di n g aller gies or dr u g se nsit i vity,  will be
rec or de d. A n y c o nc omit a nt t hera p y ta ke n i n t he 3 0 da ys prior t o t he Scree ni n g Visit
a n d t hr o u g h o ut t he st u d y will als o be rec or de d.
6. 5. Ge ner al P h ysic al E x a mi n ati o n
T he I n vesti gat or or t heir desi g nee will perf or m a p h ysical e xa mi nat i on w hic h s h o ul d 
i ncl u de assess me nt of t he f oll owi n g b o d y  s yste ms as a p pr o priate: Ce ntral Ner v o us 
S y st e m ( C N S); e yes; ears, n ose a n d t hr oat ( E N T); res pirat or y; car di ovasc ular; GI ; 
m usc ul os keletal; ne ur ol o gical; e n d ocri ne/ meta b o lic; hae mat o p oietic/l y m p hatic; 
d er m at olo gi cal.
T he o utc o me o f t hese assess me nts will be d oc u me nte d i n t he C R F a n d a n y 
a b n or malities will be descri be d. T he I n vesti gat or ca n i nter pret i n di vi d ual fi n di n gs 
base d o n t he partici pa nt’s a ge, p h ysical state a n d le vel of fit ness. Parti ci pa nts wit h 
cli nicall y si g nifica nt fi n di n gs o utsi de t he n or mal ra n ge s h o ul d be e xcl u de d fr o m t he 
st u d y base d o n i n vest i gat or’s discretio n. T his decisi o n will be d oc u me nte d o n t he 
C o m me nts pa ge of t he C R F.
6. 6 . Vit al Si g ns
Q ualifie d site staff will rec or d partici pa nt’s heart rate a n d oral b o d y  t e mperat ure w he n 
parti ci pa nts are resti n g i n a sitt i n g p ositi o n, c hec ke d a gai nst t he f oll ow i n g n or mal 
ra n ges ( w hic h are gi ve n as a g ui de) a n d rec or de d i n a p pr o priate f or ms.
He art r ate:
7 0- 1 1 0 beats per mi n ute.
Or al b o d y Te m per at ure:
9 7. 7 – 9 9. 5 ° F
T he I n vesti gat or ca n i nter pret i n di vi d ual fi n di n gs base d o n t he partici pa nt’s a ge, 
p h ysical state a n d level of fit ness. Parti ci pa nts wit h cli nicall y si g nifica nt rea di n gs 
o utsi de t he n or m al ra n ge s h o ul d be e xcl u de d fr o m t he st u d y base d o n i n vesti gat or’s 
di scretio n. T his decisi o n will be d oc u me nte d o n t he C o m me nts pa ge of t he e C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 7 of 1 2 2

6. 7 . A nt hr o p o metric Me as u re me nts ( Hei g ht, Wei g ht , B MI a n d H A Z)
All a nt hr o p o metric meas ure me nts will be perf or me d usi n g t he g ui deli nes a d o pte d at 
t he Natio nal  I nstitute of Healt h s p o ns ore d Arlie C o nfere nce [ A nt hr o p o metric 
Refere nce Ma n ual, 1 9 8 8].
H ei g ht will be meas ure d usi n g a p or ta ble sta dio- meter ( S E C A 2 1 3), wit h t he s u bject 
sta n di n g bare-f oot, t o t he nearest 0. 1 c m. A n a vera ge of 3 meas ure me nts will be 
rec or de d.
Wei g ht will be meas ure d i n sta n dar d cl ot hi n g o n sta n dar di se d wei g hi n g scale ( S E C A 
8 7 4) t o t he nearest 0. 1 k g. Wei g ht w ill be meas ure d i n t he u nit k g a n d a n a vera ge of 3 
meas ure me nts will be rec or de d.
B MI will be calc ulate d usi n g t he f o ll owi n g f or m ula:
B MI = Wei g ht k g / ( Heig ht m )2
H A Z will be o btai ne d usi n g t he W orl d Healt h Or ga nisati o n ( W H O) A nt hr o pl us 
s oft ware a vaila ble at htt p:// w w w. w h o.i nt/ gr o wt href/t o ols/e n/ ( W H O A nt hr o Pl us f or 
pers o nal c o m p uters Ma n ual: S oft ware f or assessi n g gr o wt h of t he w o rld' s c hil dre n 
a n d a d o lesce nts. Ge ne va: W H O, 2 0 0 9).
6. 8 . H b Assess me nt
A n o n -i n vasi ve s pectr o p h ot o metr y base d i nstr u me nt ( Masi m o Pr o nt o 7 P ulse C O -
O xi me ter) will be use d f or H b assess me nt. T he Masi m o
Pr o nt o 7 P ulse C O -O xi meter 
uses si g nal e xtracti o n tec h n o l og y  p ulse o xi metr y. 
Si te staff will select a n a p pr o priate size d se ns or. T he se ns or will be place d o n t he nail 
of  ri n g fi n ger of t he left ha n d, f ollo we d b y assess me nt of hae m o gl o bi n b y pressi n g 
t he test b utt o n. A p pr o priate care will be ta ke n b y t he site staff t o e ns ure t hat t he 
parti ci pa nt’s test fi n ger nail d oes n ot c o ntai n a n y nail pai nt. 
6. 9 . C ollecti o n, St or a ge, Assess me nt a n d Destr ucti o n of H u m a n 
Bi ol o gic al S a m ples 
H u m a n biol o gi c al  sa m ples will be c ollecte d wit h pri or c o nse nt (fr o m pare nts/ L A Rs)
a n d asse nt (fr o m partici pa nts) as per t he st u d y  s c h e d ule. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 8 of 1 2 2

All c ollecte d sa mples will  be c o de d wit h u ni q ue i de ntifiers a n d trac ke d u ntil
destr ucti o n . S a m pl es m ust be clearl y  la bele d wit h t he scree ni n g n u m ber, pr ot oc ol 
n u m ber, site/ ce ntre n u m ber, a n d visit date. U n der n o circ u msta nces s h o ul d a c ollec te d 
sa m ple be left u ni de ntifie d. Details f or t he pre parati o n a n d s hi p me nt of sa m ples wi ll 
be pr o vi de d i n t he la b orat or y ma n ual . 
S a m ples will  be st ore d in re q uisite st ora ge c o n diti o ns me nt i one d f or res pecti ve 
sa m ples. Sa m ples will be pr ocesse d a n d s hi p pe d t o la b orat or y as per details 
me nt i one d i n t he la b orat or y  ma n ual.
I M M E DI A T E L Y A F T E R C O L LE C TI O N, S A M P L E S WI L L B E F R O Z E N A T 
O R B E L O W -2 0° C. I F F R E E ZI N G I S N O T P O S SI B L E, T H E Y WI L L B E 
R E F RI G E R A T E D I M M E DI A T E L Y A T 2 - 8° C A N D M AI N T AI N E D A T T HI S 
T E M P E R A T U R E F O R N O L O N G E R T H A N 4 H O U R S , B E F O R E S E R U M 
S E P A R A TI O N A N D S U B S E Q U E N T F R E E ZI N G A T O R B E L O W - 2 0° C . 
S A M P L E S I F S T O R E D F O R A P E RI O D B E Y O N D E X PI R Y O F S T A BI LI T Y 
A T - 2 0°C S H O U L D B E F R O Z E N A T O R B E L O W -7 0° C.
A L L S A M P L E S ( B A S E LI N E A N D E N D -LI N E) WI L L B E A N A L Y S E D I N 
B A T C H E S, I N P E RI O DI CI T Y B A S E D O N T H EI R S T A BI LI T Y A T -2 0 ° C O R 
-7 0 ° C (I F S T O R E D F O R A P E RI O D B E Y O N D E X PI R Y O F S T A BI LI T Y O F 
S A M P L E S A T - 2 0° C). 
H B S T O B E S T O R E D TI L L I T I S P R O P E R L Y DI S P O S E D O F A T T H E E N D 
O F I T S R E T E N TI O N P E RI O D (I. E. TI L L S T U D Y R E P O R T I S I S S U E D), O R 
U S E F U L LI F E (I. E. TI L L E X PI R Y O F S T A BI LI T Y A T - 7 0°C), O R U P O N 
R E C EI P T O F A R E Q U E S T T O D E S T R O Y T H E H B S D U E T O 
WI T H D R A W A L O F C O N S E N T.
N O S A M P L E WI L L B E R E T AI N E D 
B E Y O N D 1 Y E A R F R O M L A S T P A R TI CI P A N T L A S T VI SI T .
6. 9 . 1. C ollecti o n a n d St or a ge of H u m a n Bi ol o gic al S a m ples
6. 9. 1. 1. Uri ne S a m ples
Uri ne sa m ples will be c o llecte d f or Lact ul ose: Ma n nit ol test a n d Uri nar y Ne opteri n 
test.
F or Uri n ar y Ne o pteri n test , s p o nta ne o us ra n d om uri ne will be c o llecte d. As t his test 
d oes n ot re q uire a n y s o l uti on t o be a d mi nistere d, uri ne sa m ple f or t his test will be 
c ollecte d pri or t o a d mi nistrati o n of Lact ul ose/ Ma n nit o l s ol uti on.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 5 9 of 1 2 2

A uri ne v o l ume of 2 m L per partici pa nt will be st ore d i n c o de d cr yo vials C O NI C A L 
B O T T O M T U B E S a n d t he n will be tra nsferre d t o la b orat or y a n d st ore d u n der -8 0º C
f or furt her a nal ysis.
F or L act ul ose: M a n nit ol test , T he Lact ul ose - Ma n nit ol s ol uti on t o be use d i ncl u des
2 5 0 m g/ m L of  la ct ulose a n d 5 0 m g/ m L of ma n nit ol ( 1 0 0 2 m Os m/ L), a n d will be 
a d mi nistere d at a d ose of 2 m L/ k g u p t o a ma xi m u m o f 2 0 m L. All uri ne passe d o ver 
d urati o n of  2 ½ h o urs [ A kra m S et al. , 1 9 9 8, Se q ueira I R et al, 2 0 1 4] will be c ollecte d 
after a d mi nistr atio n of Lact ul ose: Ma n nit ol  s olut i on. A pri or 3 h o urs fasti n g is 
esse nt ial bef ore a d mi nistrati o n of test s ol uti o n. Partici pa nts will be all o we d t o ret ur n 
t o t heir re g ular diet 3 0 mi n utes after i n gest i on of t he lact ul ose: ma n nit o l test s olut i on.
D uri n g t h e 2 ½ h o ur ti me, partici pa nts will be offere d li q ui ds fre q ue nt l y i n or der t o
per mit c ollect i on of a n a de q uate v o l ume of uri ne. T he start a n d st o p ti me f or t he 2 ½
h o ur d urati o n will be rec or de d f or eac h partici pa nt. After 2 ½ h o ur uri ne c o llecti on
t otal uri ne v o l ume will be meas ure d a n d rec or de d.
Fr o m  t he e ntire c ollecti on of uri ne i n a c o ntai ner, 2 m L well mi xe d uri ne sa m ple will
be tra nsferre d i n c o de d cr yo vials RI A VI A L S . Re mai ni n g uri ne sa m ples will be 
di scar de d as bi o me dical waste. T he desi g nate d st u d y  staff will place all uri ne
sa m ples i nt o a zi p-l oc k ba g c o ntai ni n g a bs or be nt t o weli n g. All s peci me ns will be
refri gerate d ( or ke pt c ol d i n a c o oler wit h a fr oze n ice pac k) u ntil tra ns p orte d t o t he
la b orat or y for a nal ysis. T he c o ol er will be sec urel y seale d wit h ta pe a n d se nt t o t he
La b orat or y , pr efera bl y o n t he sa me da y as c ollecti o n. 
I mme diatel y after c ollecti o n, freeze sa m ples at or bel o w -2 0° C. If freezi n g is n ot 
p ossi ble, refri gerate i m me diatel y at 4° C a n d mai nt ai n at t his te m perat ure f or n o 
l on ger t ha n 2 4 h o urs (i deall y less t ha n 2 h o urs) bef ore freezi n g at or bel o w -2 0° C. 
All sa m ples ( baseli ne a n d e n d-li ne) will be a nal yse d i n batc hes, i n peri o dicity base d 
o n t heir sta bilit y data at -2 0 ° C.
6. 9. 1. 2. S ali v a S a m ples
Sali va sa m ple will be c o llecte d for assess me nt of sI g A. W h o le sali va is t he g ol d 
sta n dar d w he n c ollecti n g oral fl ui d f or bi ol ogi cal testi n g. Si nce sI g A is l ocat i on 
de pe n da nt [ Beltzer, E. K. et al, 2 0 1 0] [ Cra wf or d, J. M et al, 1 9 7 5], w h ole sali va 
sa m ple a v oi ds locali se d secret i ons of s pecifi c sali var y gla n ds pr o vidi n g a m or e 
c o nsiste nt s peci me n. T h us, sali va sa m ples will be c ollecte d fr o m eac h partici pa nt 
usi n g passi ve dr o ol  met h o d wit h Sali va C ollecti on Ai d ( S C A) as descri be d b y t he 
ma n ufact urer ) ( Sali metrics, State C olle ge, P A).
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 0 of 1 2 2

Sali va will be c ollecte d usi n g S C A. Ri b be d -e n d of t he S C A will be sec urel y place d
i nto a pr e -la bele d c ollecti o n vial. Partici pa nts will be i nstr ucte d t o p o ol t he sali va i n 
m o ut h. S C A will be place d o n m o ut h e ntr y . T he n, partici pa nts will be as ke d t o tilt t he 
hea d f or w ar d, a n d ge nt l y f orce sali va t hr o u g h t he S C A i nt o t he vial t o fill with at l east 
5 0 μ L of v o l ume.  A s mall a m o u nt of air s pace will be reser ve d i n t he vial t o 
acc o m m o date li q ui d e x pa nsi o n d uri n g freezi n g. After c ollecti o n of sa m ple, S C A will 
be re m o ve d a n d discar de d a n d ca p will be attac he d t o c ollecti on vial a n d ti g hte n e d.
I mme diatel y after c ollecti o n, freeze sa m ples at or bel o w -2 0° C. If freezi n g is n ot 
p ossi ble, refri gerate i m me diatel y at 4° C a n d mai nt ai n at t his te m perat ure f or n o 
l on ger t ha n 2 4 h o urs ( i deall y less t ha n 2 h o urs) bef ore freezi n g at or bel o w -2 0° C. 
S a m ples if st ore d f or m ore t ha n 4 m o nt hs s h o ul d be fr oze n at -8 0° C.
All sa m ples ( baseli ne a n d e n d-li ne) will be a nal yse d i n batc hes, i n peri o dicity base d 
o n t heir sta bilit y at -2 0 ° C (if st ore d f or less t ha n 4 m o nt hs) or -8 0 ° C (if st ore d f or 
m o re t ha n 4 mo nt hs) .
6. 9. 1. 3. Bl o o d S a m ples
After a p plicat i on of a n a nest het ic patc h/ oi ntme nt E. G . LI D O C AI N, T E T R A C AI N 
E T C t o re d uce disc omf o rt, a t otal v ol ume o f a p pr o xi matel y 7 m L (eac h at scree ni n g 
a n d b aseli ne visit A N D E N D O F S T U D Y VI SI T , t otal of a p pr o xi matel y 1 4 m L) of  
w h o le bl o o d will be c o llecte d fr o m eac h partici pa nt b y a certifie d p hle b ot o mist f or 
bi oc he mical a n d micr o n utrie nt a nal ysis.
T he parti ci pa nt will be ma de t o LI E D O W N O N B E D or sit c o mf o rta bl y o n a c hair 
wi t h his ar m stretc he d o n t he ta ble. He/s he will be as ke d t o e xercise t he ar m s o as t o 
ma ke t he a nte -c u bital vei n pr o mi ne nt. A t o ur ni q uet will be tie d a b o ut 2 i nc hes a b o ve 
t he vei n o n t he u p per ar m. T he vei n will be pal pate d, a n d t he area will be sterilise d. 
T he vei n will be pric ke d a n d vac utai ner place d i n p osit i on t o c ollect sa m ple. Bl o o d 
sa m ples will be c ollecte d i n si n gle vial ( 7 ml eac h) T W O VI A L S ( 3. 5 M L E A C H)
b y desi g nate d staff.
After c ollect i on, all bl o o d sa m ples will be c o de d a n d r efrigerate d i m me diatel y at 
t e mperat ure ≤ 4° C a n d will be mai ntai ne d at t his te m perat ure f or n o l o n ger t ha n 2 4 
h o urs (i deall y less t ha n 2 h o urs). At t he la b orat or y , t hese sa m ples will be c o n verte d 
i nto ser u m  a n d t he n preser ve d i n ali q u ots at ≤ -2 0 ° C, u nt il f urt her re q uire d a nal yses 
are perf or me d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 1 of 1 2 2

All sa m ples ( baseli ne a n d e n d-li ne) will be a nal yse d i n batc hes, i n p eri o di cit y base d 
o n t heir sta bilit y d at a at -2 0 ° C.
6. 9 . 2. L a b or at or y Assess me nt a n d Destr ucti o n of H u m a n Bi ol o gic al S a m ples
All sa m ples will be a nal yse d at t he e n d of st u d y as per sta n dar d o perati n g pr oce d ures 
a n d vali date d tec h ni q ues / met h o ds. All pr ot oc ol re q uire d la b orat or y  assess me nts, 
m ust be c o n d ucte d i n acc or da nce wit h t he La b orat or y  Ma n ual or acc or di n g t o t he 
la b orat or y s e ctio n of  t he Pr ot oc ol, a n d Pr ot oc ol Sc he d ule of E ve nts.
P os t la b orat or y assess me nt, all sa m ples will be st ore d i n re q uisite st ora ge c o n diti ons 
me nt i one d f or res pecti ve sa m ples a n d will be destr o y e d wit hi n o ne year after last 
parti ci pa nt last visit. N o  biol o gi cal sa m ples s h o uld be destr o ye d wi t ho ut a pri or 
wri tte n a gree me nt bet wee n G S K C H a n d t he st u d y ce ntres.
6. 1 0 . Diet ar y C o u nselli n g
Di et ar y c o u nse lli n g sessi ons will be a d mi nistere d at sc h o ol. It will be a d mi nistere d t o 
all st u d y p artici pa nts a n d t heir pare nts/ L A Rs. It is prefera ble t hat b ot h pare nts of 
parti ci pa nts are pr o vi de d dietar y c o u nseli n g, b ut i n case if it is n ot p ossi ble t he n eit her 
of  mot h er or fat her will be pr o vi de d dietar y c o u nselli n g. Se parate sessi ons of dietar y  
c o u nseli n g will be hel d f or partici pa nts a nd pare nts/ L A Rs. At te n da nce b y t he sc h o ol 
teac hers will be str o n gl y e nc o ura ge d . St u d y  diet icia ns wi ll a d mi nister, s u per vise a n d 
e ns ure deli ver y of c o u nselli n g as per t he sc he d ule.
A t otal o f 7, se parate sessio n s for st u d y  partici pa nts a n d pare nts/ L A R as des cri be d i n 
ta ble belo w:
Sessi o n N o
N utriti o n al E d uc ati o n al 
C o u nse lli n g
D ur ati o n (i n mi n)
Sessi o n 1
Deli ver y  of c o nte nts
6 0 + u p t o 1 0 mi n
Sessi o n 2
6 0 + u p t o 1 0 mi n
Sessi o n 3
F o ll ow u p of  c o nte nts deli vere d i n 
Sessi o n 1 a n d 2 : Rei nf orce me nt a n d
Pr o ble m S ol vi n g
3 0 + u p t o 1 0 mi n
Sessi o n 4
3 0 + u p t o 1 0 mi n
Sessi o n 5
3 0 + u p t o 1 0 mi n
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 2 of 1 2 2

Sessi o n 6
3 0 + u p t o 1 0 mi n
Sessi o n 7
3 0 + u p t o 1 0 mi n
C o u nseli n g will be pr o vi de d b y diet icia n/ n utriti onist, well verse d wit h l ocal la n g ua ge 
a n d wi t h effect i ve ed ucat i on a n d c o u nseli n g s kills. C o nte nt s of  t he dietar y c o u nseli n g 
will be s oci o -c ult urall y acce pta ble a n d e x plai ne d i n t he la n g ua ge partici pa nts, pare nts 
a n d teac hers ca n u n dersta n d. C o nte nts of dietar y  c o u nseli n g will be base d o n t he 
Di et ar y G uideli nes f or I n di a ns, esta blis he d b y t he I n dia n C o u ncil o f Me dical 
Researc h ( Nati o nal I nst itute of N utrit i on), a n d wi ll be pr o vide d as per A p pe n di x 8 .
St u d y  diet icia n/ n utritio nist will  be i nstr ucte d t o c o ver eac h t o pic descri be d u n der eac h 
sessi o n, a de q uatel y s o as t o fi nis h t he sessi on wi t hi n t he sti p ulate d ti me. Start ti me 
a n d e n d ti me of eac h sessi o n will  be ca pt ure d i n e C R F.
Eac h sessi o n will be f o ll owe d b y u p t o 1 0 mi n of q uesti o n -a ns wer sessio n . 
Res pect f ul, scie nce-base d a ns wers t o partici pa nts’ q uesti o ns will be deli vere d.
Eac h partici pa nt/ pare nt (eit her of m o t her or fat her)/ L A R is re q uire d t o atte n d all 
di et ar y c o u nseli n g sessi ons o n ‘ deli ver y  of c o nte nts’ (i.e. sessi on n u m ber 1 & 2) a n d 
mi ni m u m o f t hree o ut of fi ve ‘f oll ow u p’ di et ar y c o u nselli n g sessi ons (i .e. sessi o n 
n u m ber 3, 4, 5, 6 & 7). Partici pa nt will be c o nsi dere d as n o n- c o m p lia nt if t he 
parti ci pa nt/ pare nt/ L A R d oes n ot atte n d eit her of sessi o n n u m ber 1 & 2 O R t hree or 
m o re sessio n s o ut of sessi on n u m ber 3, 4, 5, 6 & 7.
I n case, if a n y dietar y c o u nsellin g sessi o n  is n ot c o n d ucte d d ue t o reas o ns s uc h as 
sc h o ol e xa ms, l on g sc h o ol h o li da ys etc, t he ne xt sessi on f or diet ar y c o u nseli n g will be 
p ost p o ne d a n d c o n d ucte d as s o o n as partici pa nt is a vaila ble i n sc h o ol a n d e xa ms are 
fi nis he d. H o we ver, last dietar y  co u nselli n g sessi o n (i .e. sessi on n o 7), i n a n y sce nari o, 
will n ot be c o n d ucte d a n y  later t ha n t he last da y of 8t h m o nt h of i nter ve nti o n peri o d of  
a partic ular s u bject .  A mi ni m u m of  4 wee ks of  ga p bet wee n c o nse c uti ve c o nte nt 
deli ver y  s essio n  a n d f oll ow u p sessi on (i .e. bet wee n sessi on 2 a n d 3) ; a n d t wo 
c o nsec ut i ve f oll ow u p di et ar y c o u nselli n g sessi ons (i.e. bet wee n sessi on 2, 3, 4, 5, 6 
a n d 7) m ust be mai ntai ne d .
6. 1 1 . Cli nic al O utc o mes Assess me nt
6. 1 1. 1. C ase/Ill ness defi niti o n
F or t he p ur p ose of st u d y , GI a n d res pirat or y ill nesses will be e val uate d . T hese st u d y 
ill nesses are defi ne d as f oll ows: 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 3 of 1 2 2

A.
GI ill ness: A n ac ute ill ness t hat i ncl u des a n y of f o ll owi n g s y m pt o m s: 3 or mor e 
l oose /li q ui d/ water y st o ols a n d/ or a n y vo mit i n g i n 2 4 h o urs [ W H O, 2 0 16 ] [ Az or-
Mar ti nez E et al, 2 0 1 4]. 
Di arr hea, v o mit i n g arisi n g d ue t o no n -i nfecti ous ca uses , s uc h as Irrita ble B o wel 
S y n dr o me (I B S), a n d me dicat i ons will  be e xcl u de d fr o m t he dia g n osis.
B.
Res pir at or y ill ness : A n ac ute ill ness t hat i ncl u de d ≥1 of t he f o ll owi n g 
s y m pt o ms: ru n n y n ose, st uff y or bl oc ke d n ose, c o u g h, fe ver or c hills, s ore t hr oat, 
or s neezi n g [ Sa n d ora et al. 2 0 1 6] . 
S y m pt o m s arisi n g d ue t o n o n- i nfectio us ca uses (e. g., aller g y) will be e xcl u de d
fr om t he dia g n osis.
6. 1 1. 2. M or bi dit y
O utc o mes D efi niti o ns
F o ll owi n g m o r bidi t y o ut c o mes wit h res pect t o GI a n d res pirat or y ill nesses are g oi n g 
t o be e val uate d i n t he st u d y:
A.
N u m ber of ill ness d a ys : Nu m ber of da ys a parti ci pa nt is ill beca use of GI a n d/ or 
res pir at or y ill nesses as dia g n ose d b y st u d y p h ysicia n, as per t he crite ria defi ne d, 
o ver t he i nter ve nti o n d urat i on. T hi s c orres p o n ds t o t otal n u m ber of da ys 
(s y m pt o mat ic or as y m pt o matic) i n a n e pis o de of ill ness.
B.
Fre q ue nc y of ill nesses : T otal nu m ber of ill ness e pis o des of  GI a n d/ or res pirat or y 
ill nesses, di vi de d b y  d ur atio n of  int er ve nt i on, w here eac h e pis o de is defi ne d as 
eac h i nci de nce of il l ness f oll owe d b y  at least 3 s y m pt o m free da ys [ Az or-
Martí nez et al., 2 0 1 4] [ Barret o M L et al., 1 9 9 4] [S ur D et al., 2 0 0 3]. 
F or t he p ur p ose of st u d y , eac h occ urre nce of a n ill ness is de fi ne d as a n e ve nt 
w hic h i nc or p orates a peri o d w hic h i ncl u des all ill ness da ys u ni nterr u pte d b y  a n y 
s y m pt o m free da y. T h us, a n e pis o de ma y c o nsist of o ne or m ore t ha n o ne 
occ urre nces of ill ness. 
C.
Se verit y of a n ill ness e pis o de: I nte nsit y of GI an d/ or res pir at or y ill nesses; WI L L 
B E E V A L U A T E D A N D C L A S SI FI E D A S P E R C RI T E RI A S P E CI FI E D I N 
A P P E N DI X -5  (B A S E D O N C T C A E 2 0 1 0 )w hic h is e val uate d a n d classifie d as 
f oll ows: 

Se verit y of  GI ill nesses [C T C A E 2 0 1 0]
a.
Di arr h oea:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 4 of 1 2 2


Mil d, ≤3 l o ose st o ol s/ da y 

M o derate, 4 t o 6 l o ose st o ols/ da y  

Se vere, ≥7 l o ose st o ols/ da y
b.
V o mit i n g: 

Mil d, 1 t o 2 b o uts/ da y

M o derate, 3 t o 5 b o uts/ da y

Se vere, ≥6 b o uts/ da y   

Se verit y of  res pir at or y ill nesses

Mil d - Easil y t ol erate d, ca usi n g mi ni mal disc o mf o rt a n d n ot i nterferi n g 
wi t h n or mal e ver yd a y  acti vities.

M o derate – S ufficie nt l y disc o mf orti n g t o i nterfere wit h n or mal 
e ver y da y act i vities.

Se vere – A n y e ve nt t hat pre ve nts n or mal e ver y da y acti vit ies.
D.
Sc h o ol a bse nteeis m : N u m ber of da ys w he n a c hil d fails t o atte n d sc h o ol beca use 
of  GI a n d/ or res pirat or y ill nesses.
6. 1 1. 3. Cli nic al E v al u ati o n T o ols
A. P are nt/ L A R re p orte d S y m pt o m C hec klist
At  t he be gi n ni n g of t he st u d y, pare nts/ L A Rs will  be pr o vide d wi t h bla n k ‘s y m pt o m  
c hec klist’ f or ms. T he s y m pt o m c hec klist t o be use d b y t he pare nts/ L A Rs has bee n 
a p pe n de d ( A p pe n di x 3). W he n a s y m pt o m is o bser ve d i n t he parti ci pa nt d uri n g t he 
i nter ve nt i on peri o d, t he pare nts will be re q uire d t o fill t he s y m pt o m c hec klist as 
trai ne d b y st u d y staff. T he se verity/ i nte nsit y of se verit y assess me nt of t he s y m pt o ms 
e. g. s ore t hr oat, dr y c o u g h, wet c o u g h, r u n n y nose, st uff y/ bl oc ke d n ose a n d s neezi n g
will be ma de b y  pare nts/ L A Rs as per t he f oll o wi n g criteria:

Mil d – E asil y t olerate d, ca usi n g mi ni mal disc o mf o rt a n d n ot i nterferi n g wit h 
n or m al e ver y da y acti vities.

M o derate – S ufficie nt l y disc o mf orti n g t o i nterfere wit h n or mal e ver y da y 
acti vit ies.

Se vere – A n y e ve nt t hat pre ve nts n or mal e ver y da y acti vit ies.
Pare nts/ L A Rs will be trai ne d b y st u d y  staff t o assess t he s y m pt o ms base d o n a b o ve 
cr iteria. F or t he assess me nt of ot her s y m pt o ms e. g. diarr hea/l o ose st o ols, v o mit i n g 
a n d fe ver, t he criteria are alrea d y me nt i one d i n t he s y m pt o m c hec klist w hic h are i n 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 5 of 1 2 2

li ne wit h assess me nt d o ne as per C T C A E 2 0 1 0. Pare nts/ L A Rs will als o be pr o vi de d 
wi t h digi tal t her mo m eters t o c hec k te m perat ure i n case if fev er i s o bser ve d.
I n cases w here pare nts/ L A Rs d o n ot o bser ve a n y s y m pt o ms i n t he parti ci pa nt , t he y 
will be as ke d t o mar k t he rele va nt (‘ N o’) b o x me nti o ne d f or eac h s y m pt o m f or eac h 
d a y  in t he s y m pt o m  c hec klist. T he s y m pt o m c hec klist will be ha n de d t o st u d y 
p h ysicia n o n wee kl y  basis f or re vie w b y p h ysicia n. T he p h ysicia n will t he n e val uate 
t he s y m pt o ms, if a n y, t o deter mi ne dia g n osis. 
T h ose re q uiri n g h os pitalisat i on or s pecialise d care will be referre d t o t he sec o n dar y or 
t ertiar y care h os pit al, as dee me d necessar y b y t he st u d y p h ysicia n. T he deter mi ne d 
di a g n osis will be ca pt ure d i n t he C R F, a n d t he se verit y will be gra de d base d o n t he 
crit erio n i n dicate d i n A p pe n di x 5.
B.
Di a g n osis F or m
Di a g n osis f or m ( D F) will use d t o n ote t he di a g n osis, se verity a n d sc h o ol a bse nteeis m 
d ue t o GI a n d res pirat or y ill nesses o nl y , as defi ne d i n t he st u d y pr ot oc ol. D F w ill als o 
be use d t o ca pt ure start a n d e n d date of all occ urre nces of GI a n d res pirat or y ill nesses
i n t he wee k. 
Ot he r mor bi di t y o ut c o mes s uc h as n u m ber of ill ness da ys, n u m ber of e pis o des ,
fre q ue nc y d ue t o GI a n d res pirat or y ill nesses, as defi ne d i n t he st u d y pr ot oc ol, will be 
calc ulate d pr o gra m mat icall y usi n g statistical a nal ysis s oft ware ( S A S). 
D ata o n dia gn osis a n d m o r bi dit y o ut c o mes b y st u d y p h ysicia n o n t he D F will be use d 
f or a nal ysis. D F will be fille d as per t he details o btai ne d fr o m:

S y m pt o m c h ec klist fille d b y pare nts/ L A Rs

E xter nal cli nical rec or d, if treate d b y  a n e xter nal p h ysicia n

Di rect i nf or mati o n b y p artici pa nts/ pare nts/ L A Rs 

C li nical hist or y  a n d e xa mi nati on b y st u d y  p h ysicia n
6. 1 2 . St u d y P h ysici a n Wee kl y Re vie w
T o e ns ure t hat n o case is misse d, a wee kl y re vie w ( S P W R) will be sc he d ule d b y t he 
st u d y p h ysicia n t o c hec k s y m pt o m c hec klist fr o m all partici pa nts. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 6 of 1 2 2

S P W R will i nit iate 1 wee k ( + u p t o 2 da ys) p ost first dietar y c o u nselli n g visit of t he 
parti ci pa nt a n d will c o nt i n ue o n a wee kly basis ( + u p t o 2 da y s) u ntil e n d of st u d y 
v isit. At  least o ne wee kl y re vie w wit h t he st u d y p h ysicia n will occ ur after pr o d uct 
a d mi nistrati o n st o ps L A S T S P W R WI L L B E C O N D U C T E D O N E N D O F 
S T U D Y VI SI T D A Y, E V E N I F S Y M P T O M S A R E A S S E S S E D F O R L E S S 
T H A N A W E E K I N S Y M P T O M C H E C K LI S T F O R M .
I n case t he S P W R of  a partici p a nt is n ot c o n d ucte d d ue t o reas o ns s uc h as 
a bse nteeis m, l on g h o li da ys etc f or a wee k, t he n e ver y atte mpt will  be ma de t o c o ntact 
a n d c o llect s y m pt o m c hec klist fr o m partici pa nt/ pare nts/ L A Rs, eit her tele p h o nicall y or 
visit i n g t he m at h o me. If a n y p artici pa nt is n ot accessi ble f or c o nsec uti ve 4 wee ks , 
he/s he will be c o nsi dere d as l ost t o f oll ow u p. 
6. 1 2. 1. C ollecti o n of S y m pt o m C hec klist
Pare nt/ L A R -re p orte d s y m pt o m c hec klist will b e c ollecte d o n eac h wee kl y re vie w. 
P h ysicia n will re vie w t he pare nt/ L A R S y m pt o m  c hec klist a n d c o n d uct cli nical
e xa mi nat i on of o nl y  t h ose partici pa nts w h o prese nt wit h s y m pt o ms o n t he s y m pt o m 
c hec klist or i nf or m t he p h ysicia n direct l y. 
6. 1 2. 2 .
St u d y P h ysici a n Cli nic al Hist or y a n d E x a mi n ati o n
St u d y  p h ysicia n will be ma de a vaila ble at sc h o ol o n all sc h o ol da ys d uri n g sc h o ol 
ti mi n gs.      
W he n t he par tici pa nt f alls sic k at sc h o ol d uri n g sc h o ol  ti mi n gs with t he pre -s pecifie d 
s y m pt o ms relate d t o GI a n d res pirat or y ill nesses, partici pa nt will be prese nte d t o t he 
st u d y p h ysicia n. St u d y p h ysicia n will c ollect rele va nt cli nical hist or y fr o m 
parti ci pa nts a n d pare nts/ L A Rs (if a vaila ble). St u d y p h ysicia n will s yste maticall y 
e val uate t he s y m pt o ms usi n g well -defi ne d, pre -esta blis he d criteria a n d will ma ke 
o bj ect i ve dia g n osis of t he cli nical o utc o mes, as defi ne d i n t he st u d y pr ot oc ol.
W he n st u d y  p artici pa nt f all sic k b ut are n ot at sc h o ol (e. g. duri n g h oli da ys, aft er 
sc h o ol dis missal etc), wit h t he pre -s pecifie d s y m pt o ms relate d t o GI a n d res pirat or y 
ill nesses, pare nt s/ L A Rs w o ul d nee d t o c o m pl ete t he ‘s y m pt o m c hec klist’ pr o vi de d t o 
t he m. S y m pt o m c hec klist w o ul d be prese nte d t o st u d y p h ysicia n b y t he partici pa nts/ 
pare nts/ L A Rs. I n case, if a n e xter nal p h ysicia n is c o ns ulte d f or t he treat me nt, cli nical 
rec or d f or m fr om t he sa me w o ul d als o be prese nte d t o t he st u d y p h ysicia n al o n g with 
s y m pt o m c hec klist. St u d y p h ysician will c o llect rele va nt cli nical hist or y fr om 
parti ci pa nts a n d pare nts/ L A Rs (if a vaila ble). St u d y p h ysicia n will e val uate a n d verif y  
pare nt re p orte d data o n s y m pt o m c hec klist a n d cli nical rec or d f or m fr o m e xter nal 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 7 of 1 2 2

p h ysicia n. St u d y  p h ysicia n will s yste mat icall y e val uate t he s y m pt o ms (if still prese nt 
i n t he partici pa nts) usi n g well -defi ne d, pre -esta blis he d criteria a n d will ma ke 
o bj ect i ve dia g n osis of t he cli nical o utc o mes, as defi ne d i n t he st u d y pr ot oc ol.
Di a g n osis b y st u d y p hysicia n o n D F will  be use d f or a nal ysis. I n case o f a c o nflict 
bet wee n pare nt -re p orte d s y m pt o ms, e xter nal p h ysicia n’s re p orte d dia g n osis a n d st u d y 
p h ysicia n’s dia g n osis, t he st u d y p h ysicia n’s dia g n osis will s u perse de. 
A vaila bilit y of p h ysicia n will als o e ns ure t he c hil dre n are pr o vi de d wi t h ti mel y care, 
w hic h c o ul d i ncl u de t he a d vice t o use a h y drati o n f or m ula a n d/ or me dicati o ns ( e. g.,
a nt i bi otic, nasal dec o n gesta nt) t o hel p ma na ge t heir s y m pt o ms/i nfecti o n. I f a n d w he n 
nee de d, a n d, if p ossi ble, t he sa me t y p e of  h y drati on f or mulas a n d m e dicatio ns w o ul d 
be pr o vi de d t o c hil dre n – e. g. , t he sa me t y pe of a nti bi otic, t he sa me t y pe of nasal 
dec o n gesta nt, etc.
6 . 13 . 2 4 hr Diet ar y Rec all & Diet ar y D i versit y S ur ve y 
6. 1 3 . 1. 2 4 hr Diet ar y Rec all
T his m et h o d i n v ol ves a str uct ure d i nter vie w a n d will be c o n d ucte d as per t he 
q uesti o n naire pr o vi de d i n A p pe n di x 6 . Si nce c hil dre n, i n varia bl y te n d t o 
o veresti mate, pare nts/ L A Rs s h o ul d be prese nt at t h e 2 4-h o ur recalls. Maj orit y of  t he 
i nf or mat i on s h o ul d c o me fr o m  t he pare nt/ L A Rs, with t he c hil d ma ki n g a d dit i ons t o 
fill i n t he ga ps. 
Res p o n de nts ( partici pa nt/ Pare nts / L A Rs) will als o be as ke d w het her or n ot t he da y  
recalle d is t ypi c al  of t h eir us ual fo o d c o ns u m pt i on, or if it was u n us ual or restricte d i n 
a n y wa y e. g. fast, festi val etc. If t he da y is n ot t he re prese ntati ve of a t ypical da y  t he n 
t he partici pa nt ma y be calle d f or a n ot her da y.
O n c o nfir mat i on of t he da y  bei n g a re prese ntati ve of a t ypical  d a y, a trai ne d st u d y 
staff will as k t he res p o n de nts ( partici pa nt/ p are nts/ L A Rs) t o recall all f o o d a n d 
be vera g e c o ns u me d b y t he c hil d d uri n g pre vi o us 2 4 h o urs . F o r h o me ma de f oo d a n d 
be vera ge , fol l owi n g i nf or mati o n will be rec or de d:
Li st of in gre die nts: e. g. water, oil, her bs, s pices.
A m o u nts of i n gre die nts: T his ca n be i n h o use h ol d meas ures, wei g hts or usi n g 
p orti o n si zes. 
C o o ki n g met h o d: Rec or d s o me brief i nf or mat i on o n h o w t he dis h was pre pare d 
a n d c o o ke d. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 8 of 1 2 2

T he f o o d or be vera ge ite ms w hic h are b o u g ht , na me of t he bra n d will be e n q uire d. A 
p orti o n si ze ca n be descri be d i n ter ms of eit her h o use h old meas ures (e. g. o ne le vel 
teas p o o n of s u gar, b o wl, c u p etc) or w ei g ht s.
Calc ulati o n o n e ner g y a n d t he macr o n utrie nts ( pr otei n, car b o h y drates a n d fat) will be 
ma de usi n g a p plicat i on/ s oftware . F o r t he p ur p ose latest a vaila ble Diets oft s oft ware 
a vaila ble at htt p: // diets oft.i n/ base d o n I n dia n data ( NI N a n d I C M R) will be use d .
6. 1 3. 2. Diet ar y D i versit y S ur ve y
H o use h o l d dietar y di versity refers t o t he n u m ber of differe nt f o o d gr o u ps c o ns u me d
o ver a gi ve n refere nce peri o d [ H o d di n ott a n d Y o ha n nes , 2 0 0 2].  T his meas ure is 
i m p orta nt beca use a di versifie d diet is ass ociate d wit h ma n y health be nefit s, i ncl u di n g 
m o re o pti mal c hil d a nt hr o p o metric stat us a n d i m pr o ve d H b c o nce ntrati o ns [ S wi n dale 
a n d Bili ns k y , 2 0 0 6].
Di et ar y di versit y ca n be assesse d at t he le vel of t he h o use h ol d or at t he le vel of t he 
i n di vi d ual, res ulti n g i n either a H o use h ol d Dietar y  Di versity Sc ore ( H D D S) or a n 
I n di vi d ual Dietar y Di versit y Sc ore (I D D S).  T he H D D S is a meas ure of t he 
s o cioec o n o mic stat us of t he fa mil y; t he I D D S is a meas ure of t he n utrit i onal q ualit y 
of  t he i n di vi d ual’s diet.  F or t he pr o p ose d cli nical st u d y, it is i m p orta nt t o u n dersta n d 
t he c hil d’s I D D S; he nce, t he C D D S will be deter mi ne d.
I D D S will be assesse d base d o n t he ‘G ui deli nes f or m eas uri n g h o use h ol d a n d 
i n di vi d ual dietar y di versit y’ pre pare d b y F o o d a n d A gric ult ure Or ga nis at i on ( F A O) of 
t he U nite d Nati o ns [ F A O g uideli nes di et ar y di versi t y, 2 0 1 1 ]. Detaile d i nf or mati on o n 
tra nslat i on a n d a da ptati o n , instr ucti o ns f or a d mi nisteri n g t he q uesti o n naire a n d 
anal yzi n g dietar y  di versity data will be use d as rec o m me n de d i n t he g ui deli nes.
Base d o n data o n f o o ds a n d be vera ges c o ns u me d i n last 2 4 hr as ca pt ure d b y  2 4 hr 
di et ar y s ur ve y, a p pr o priate f o o d gr o u ps i n q uest i on naire i n A p pe n di x 7, will be 
selecte d.
Di et ar y di versit y sc ores are calc ulated b y  s u m mi n g t he n u m ber of f o o d gr o u ps 
c o ns u me d b y t he c hil d o ver t he 2 4 -h o ur recall peri o d. T he sc ore ra n ges fr o m 0 t o 9, 
wi t h o ne p oi nt a war de d f or f o o ds t hat are c o ns u me d fr om eac h of t he f oll o wi n g f o o d 
gr o u ps i n t he pre vi o us 2 4 h o urs:
1.
Starc h y  st a ples
2.
Dar k gree n leaf y  ve geta bles
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 6 9 of 1 2 2

3.
Ot her vita mi n A ric h fr uits a n d ve geta bles
4.
Ot her fr uits a n d ve geta bles
5.
Or ga n meat
6.
Meat a n d fis h
7.
E g gs
8.
Le g u mes, n uts a n d see ds
9.
Mil k a n d mil k pr o d ucts
De pe n di n g u p o n I D D S, st u d y  partici pa nts w o uld be cate g ori se d i nt o t hree gr o u ps as 
f oll owi n g:

≤ 3 f o o d gr o u ps 
- L o west dietar y  di versity 

4 a n d 5 f o o d gr o u ps
- Me di u m  di et ar y di versit y 

≥ 6 f o o d gr o u ps
- Hi g h dietar y di versit y 
6. 1 3 . St u d y C o ncl usi o n
P arti cip a nts will be e val uate d t o deter mi ne if t he y c o m plete d all st u d y  pr oce d ures or 
if t he y were disc ont i n ue d fr o m t he st u d y earl y.  If t he s u bject disc o nti n ue d at a n y 
p oi nt d uri n g t he st u d y , t he pri mar y reas o n f or wit h dra wal s h o ul d be rec or de d o n t he 
St u d y  C o ncl usi on pa ge of t he C R F b y select i n g o ne of t he o pti o ns bel o w.
1.
S u bject di d n ot meet st u d y  criteria
2.
A d verse E ve nt
3.
L ost t o F oll o w U p
4.
Pr ot oc ol  Viol at i on
5.
Wit h dra wal o f C o nse nt
6.
Ot her
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 0 of 1 2 2

7 . S A F E T Y A S S E S S M E N T S
7 . 1. Defi niti o ns of a n A d verse E ve nt a n d Seri o us A d verse E ve nt 
7 . 1. 1. A d verse E ve nts
T he i n vestigat or or si te staff will be res p o nsi ble f or detecti n g, d oc u me nti n g a n d 
re p orti n g e ve nts t hat meet t he defi niti on of a n A E or S A E.
A d verse E ve nt Defi niti o n:

A n A E i s a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical 
i n vesti gati on s u bject, te m p orall y ass ociate d wit h t he use of a n i n vesti gati onal 
pr o d uct or i n vest i gati onal i n vasi ve pr oce d ures, w het her or n ot c o nsi dere d 
r elate d t o t he i n vest i gati onal or i n vest i gati onal i n vasi ve pr oce d ures.

N O T E: A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n
(incl u di n g a n a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or 
e xacer bate d) te m p orall y ass ociate d wit h t he use of a n i n vest i gati onal pr o d uct 
or i n vesti gati o nal i n vasi ve pr oce d ures.
E ve nts meeti n g A E defi niti o n i ncl u de:

A n y a b n or mal la b orat or y  test res ults (if a p plica ble) or ot her safety 
assess me nts, i ncl u di n g t h ose t hat w orse n fr o m baseli ne, a n d felt t o be 
cli nicall y si g nifica nt i n t he me dical a n d scie nt ific j u d g me nt of t he 
i n vesti gat or.

E xacer bat i on of a c hr o nic or i nter mitte nt pre -e xist i n g c on dit i on i ncl u di n g 
eit her a n i ncrease i n fre q ue nc y a n d/ or i nte nsit y of  t he c o n ditio n .

Ne w c o n dit i on(s) detecte d or dia g n ose d after st u d y pr o d uct a d mi nistrati o n or 
i n vesti gati onal i n vasi ve pr oce d ures e ve n t h o u g h it ma y ha ve bee n prese nt 
pri or t o t he start of t he st u d y.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d i nteracti o n.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her 
st u d y pr o d uct or a c o nc o mita nt me dicati on ( o ver d ose per se will n ot be 
re p orte d as a n A E/ S A E).
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 1 of 1 2 2

E ve nts N O T meeti n g defi niti o n of a n A E i ncl u de:

A n y cli nicall y  sig nifica nt a b n or mal la b orat or y  fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, 
u nless j u d ge d b y t he i n vesti gat or t o be m ore se ve re t ha n e x pecte d f or t he 
s u bject’s c o n diti on. 

T he disease/ dis or der/ c o n dit i on bei n g st u die d or e x pecte d pr o gressi o n, si g ns, 
or s y m pt o ms of t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n 
e x pecte d f or t he s u bject’s c o n ditio n .

Me dical or s ur gic al pr oce d ure (e. g., e n d osc o p y, a p pe n dect o m y): t he c o n diti on 
t hat lea ds t o t he pr oce d ure is a n A E.

Si t u atio ns w here a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A nt ici pate d da y-t o-da y fl uct uati o ns of pre-e xist i n g disease(s) or c o n diti on(s) 
prese nt or detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
7 . 1. 2. Seri o us A d verse E ve nts
Seri o us A d verse E ve nt is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at 
a n y d ose:
A.
Res ults i n de at h
B.
Is life-t hre ate ni n g
N O T E: T he ter m 'life -t hreate ni n g' i n t he defi niti on of 'seri o us' refers t o a n 
e ve nt i n w hic h t he s u bject was at ris k of deat h at t he ti me of t he e v e nt.  It d oes 
n ot refer t o a n e ve nt, w hic h h y p ot heticall y mi g ht ha ve ca use d deat h, if it were 
m o re se vere.
C.
Re q uires h os pit ali sati o n or pr ol o n g ati o n of e xisti n g h os pit ali sati o n
N O T E: I n ge neral, h os pitali sat i on si g nifies t hat t he s u bject has bee n detai ne d 
( us uall y i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y 
war d f or o bser vati o n a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n 
t he p h ysicia n’s office or o ut -pati e nt settin g.  C o m plicat i ons t hat occ ur d uri n g 
h os pi t alisat i on are A E s.  If a c o mplicat i on pr ol o n gs h os pi talisat i on or f ulfills 
a n y ot her seri o us criteria, t he e ve nt is seri o us.  W he n i n d o u bt as t o w het her 
“ h os pitalisat i on” occ urre d or was necessar y, t he A E s h o ul d be c o nsi dere d 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 2 of 1 2 2

serio us.
H os pitali sat i on f or elect i ve treat ment  of a pre-e xisti n g c o n dit i on t hat di d n ot 
w orse n fr o m baseli ne is n ot c o nsi dere d a n A E.
D.
Res ults i n dis a bilit y/i nc a p acit y
N O T E: T he ter m disa bilit y mea ns a s u bsta nt ial disr u ptio n of  a pers o n’s a bility 
t o c o n d uct n or mal life f u ncti ons.
T his defi nit i on is n ot i nte n de d t o i ncl u de e x perie nces of relat i vel y mi n or 
me dical si g nifica nce s uc h as u nc o m p licate d hea dac he, na usea, v omit i n g, 
di arr hea, i nfl ue nza, a n d acci de ntal tra u ma (e. g. s prai ne d a n kle) w hic h ma y  
i nterfere or pre ve nt e ver yd a y  life f u ncti ons b ut d o n o t c o nstit ute a s u bsta ntial 
di sr u pti on.
E.
Is a c o n ge nit al a n o m al y/ birt h defect
F.
Ot her Sit u ati o ns

Me dical or scie nt ific j u d g me nt s h o ul d be e xercise d i n deci di n g w het her 
re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as i m p orta nt me dical e ve nts 
t hat ma y no t be i m me diatel y life-t hreate ni n g or res ult i n deat h or 
h os pi t alisat i on b ut ma y je o par di se t he s u bject or ma y re q uire me dical or 
s ur gical i nter ve ntio n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve 
defi nit i on. T hese s h o ul d als o be c o nsi dere d seri o us.

E xa m ples of s uc h e ve nts are i n vasi ve or mali g na nt ca ncers, i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me for aller gi c br o nc h os pas m, bl o o d 
d y scrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitali sat i on or de vel o p me nt 
of  dr u g de pe n de nc y or dr u g ab use or re p orts of s p o nta ne o us a b orti o n.
7. 2 . Rec or di n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
Rec or di n g of a d verse e ve nts a n d seri o us a d verse e ve nts:

T he i n vest i gat or or site staff will  be res p o nsi ble f or detecti n g, d oc u me nti n g 
a n d re p orti n g e ve nts t hat meet t he defi nit i on of a n A E or S A E. 

T he i n vest i gat or or site staff will t he n rec or d all rele va nt i nf or mati on 
re gar di n g a n A E/ S A E i n t he C R F.

T here m a y be i nsta nces w he n c o pies of me di c al  rec or ds f or certai n cases are 
re q ueste d b y G S K.  I n t his i nsta nce, all s u bject i de ntifiers, wit h t he e xce pti on 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 3 of 1 2 2

of  t he s u bject n u m ber, will be bli n de d o n t he c o pies of t he me dical rec or ds 
pri or t o s u b missi o n of t o G S K.

T he i n vest i gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n 
sig ns, s y m pt o m s, a n d/ or ot her cli nical i nf or mati o n.  I n s uc h cases, t he 
di a g n osis will be d oc u me nte d as t he A E/ S A E a n d n ot t he i n di vi d ual 
sig ns/s y m pt o m s. Cli nical AEs will be descri be d b y dia g n osis a n d n ot b y  
s ym pt o ms w he n p ossi ble (e. g., u p per res pirat or y  tract i nfecti o n, seas o nal 
aller g y, etc. i nstea d of r u n n y nose).

A Es will be c o llecte d fr om t he start of t he a d mi nistrati o n of i n vesti gati onal 
pr o d uct or i n vest i gati onal i n vasi ve pr oce d ures a n d u nt il 7 da ys f ollo wi n g last 
a d mi nistrati o n of t he st u d y pr o d uct or i n vesti gati o nal i n vasi ve pr oce d ures.

S A Es will be c ollecte d o ver t he sa me ti me peri o d as state d a b o ve f or A Es.  
H o we ver, a n y  S A Es assesse d as rel ate d t o st u d y p artici pat i on (e. g., 
i n vesti gati onal pr o d uct, p r ot oc ol ma n date d pr oce d ures, i n vasi ve tests, or 
c ha n ge i n e xist i n g t hera p y) or relate d t o a G S K c o nc omit a nt me dicat i on will 
be rec or de d fr o m t he ti me a s u bject c o nse nts t o partici pate i n t he st u d y  u p t o 
a n d i ncl u di n g a n y f o ll ow- u p c o ntact.  

Me dical c o n dit i ons re p orte d pri or t o t he ti me peri o d f or re p orti n g A Es/ S A Es 
s h o uld be rec or de d as part of t he s u bject’s me dical hist or y .
7. 3 . E v al u ati n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
Assess me nt of I nte nsit y:
T he i n vest i gat or or desi gnee will ma ke a n assess me nt of i nte nsit y f or eac h A E a n d 
S A E re p orte d d uri n g t he st u d y  a n d will assi g n it t o o ne of t he f oll o wi n g cate g ories:

Mil d:  A n e ve nt t hat is easil y t olerate d b y  t he s u bject, ca usi n g mi ni mal 
di sc o mf ort a n d n ot i nterferi n g wit h e v er y da y act i vities.

M o derate:  A n e ve nt t hat is s ufficie nt l y disc omf o rti n g t o i nterfere wit h n or mal 
e ver y da y act i vities

Se vere:  A n e ve nt t hat pre ve nts n or mal e ver y da y acti vit ies. - a n A E t hat is 
assesse d as se vere will n ot be c o nf use d wit h a n S A E. Se verit y is a cate g or y 
utili se d f or rati n g t he i nte nsity of  a n e ve nt; a n d b ot h A Es a n d S A Es ca n be 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 4 of 1 2 2

assesse d as se vere.
N ote: A n e ve nt is defi ne d as ‘seri o us’ w he n it meets at least o ne of t he pre -defi ne d 
o utc o m es as descri be d i n t he defi nit i on of a n S A E.
Assess m e nt of C a us alit y:

T he i n vest i gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y pr o d uct 
a n d t he occ urre nce of eac h A E/ S A E.

A "reas o na ble p ossi bilit y" is me a nt t o c o n ve y t hat t here are facts/e vi de nce or 
ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati ons hi p ca n n ot be 
r ule d o ut.

T he i n vest i gat or will use cli nical j u d g me nt t o deter mi ne t he relati ons hi p.

Alt er nat i ve ca uses, s uc h as nat ural hist or y of t he u n derl yi n g diseases, 
c o nc o mita nt t hera p y, ot her ris k fact ors, a n d t he te m p oral relat i ons hi p of t he 
e ve nt t o t he st u d y pr o d uct will be c o nsi dere d a n d i n vesti gate d.

T he i n vest i gat or will als o c o ns ult t he I n vesti gat or Br oc h ure (I B) a n d/ or 
Pr o d uct I nf or mat i on, f or mar kete d pr o d ucts, i n t he deter mi nat i on of his/ her 
assess me nt.

F or eac h A E/ S A E t he i n vesti g at or m ust d oc u me nt i n t he me dical n otes 
(s o urce d oc u me nt) or C R F t hat he/s he has re vie we d t he A E/ S A E a n d has 
pr o vi de d a n assess me nt of ca usalit y.

T here m a y be sit u atio ns w he n a n S A E has occ urre d a n d t he i n vest i gat or has 
mi ni mal i nf or mat i on t o i ncl u de i n t he i nitial re p ort t o G S K.  H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of 
c a us alit y f or e ver y e ve nt pri or t o t he i niti al tr a ns missi o n of t he S A E d at a 
t o G S K.

T he i n vest i gat or ma y c ha n ge his/ her o pi ni on of ca us alit y i n li g ht of f oll ow- u p 
i nf or mat i on, a m e n di n g t he S A E data c ollect i on t o ol acc or di n gl y.

T he ca usalit y assess me nt is o ne of t he crit eria use d w he n deter mi ni n g 
re g ulat or y re p orti n g re q uire me nts.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 5 of 1 2 2

7. 4 . Re p orti n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
A E Re p orti n g t o G S K C H:

A Es will be rec or d e d i n t he A E sect i on of t he C R F. 

Me dical c o n dit i ons rec or de d b y  t he s u bject o n a diar y car d or si milar 
d oc u m e nt t hat meet t he defi nit i on of a n A E m ust als o be rec or de d i n t he A E 
secti on of t he C R F, if n ot pre vi o usl y well -c haracterise d b y t he i n vest i gat or i n 
t he s u bject’s me dical hist or y. 

A Es elicite d b y t he i n vesti gat or i n a sta n dar d ma n ner at t he st u d y visits s h o ul d 
als o be rec or de d i n t he A E sect i on of t he C R F.  T he i n vest i gat or or desi g nee 
m ust as k t he s u bject t he f o ll owi n g q uesti o n d uri n g eac h visit i ncl u di n g a n y 
f oll ow- u p visits : “H ave y o u felt u n well, e x perie nce d a ny sy m pt o ms or t a ke n 
a ny me dic ati o n (si nce y o ur l ast visit) (t o d ay) (si nce y o ur l ast d ose) (si nce t he 
l ast sessi o n) ? ”

T he m e dicall y q ualifie d i n vesti gat or s h o ul d re vie w a d verse e ve nts i n a ti mel y 
ma n ner; t his re vie w s h o ul d be d oc u me nte d i n writ i n g i n t he s o urce d oc u me nt 
or i n t he C R F. 

After t he st u d y  is c o mplete d at a gi ve n site, a n d t he site has recei ve d t heir 
st u d y data o n C o mpact Discs ( C Ds), t he el ectr o nic data c ollecti o n t o ol will be 
re mo ve d fr o m  t he i nter net t o pre ve nt t he e ntr y of ne w data or c ha n ges t o 
e xist i n g data.
S A E Re p orti n g t o G S K C H:
A pa per c o p y  of t he S A E f or m pr o vide d i n t he i n vesti gat or st u d y  master file s h o ul d 
be c o m p lete d as f ull y as p ossi ble. 
It is esse ntial t o e nter t he f oll o wi n g i nf or mati on: 

Pr ot oc ol  a n d s u bject ide nt ifiers

S u bject’s de m o gra p h y

Descri pt i on of e ve nts, wit h dia g n osis if a vaila ble
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 6 of 1 2 2


I n vesti gat or o pi ni on of relati o ns hi p t o st u d y  pr o d uct (see secti o n 8. 3)

Cri t erio n f or s eri o us ness.
T he f o ll owi n g are desi ra ble a n d are of partic ular rele va nce f or i n vest i gat or a n d 
G S K C H assess me nt of t he S A E re p ort:

Date of o nset of A E 

Date A E st o p pe d, if rele va nt

St u d y  pr o d uct start date

St u d y  pr o d uct e n d date if rele va nt

Act i on ta ke n o n st u d y  pr o d uct

O utc o m e if k n o w n
T he S A E f or m, c o m plete d as f ull y as p ossi ble, a n d S A E fa x c o ver s heet m ust be 
fa xe d or e-maile d t o t he a p pr o priate G S K C H St u d y Ma na ger as s o o n as p ossi ble, b ut 
n ot l ater t h a n 2 4 h o urs after st u d y site pers o n nel lear n of t he e ve nt. T he G S K C H 
St u d y  Ma na ger s h o uld be n otifie d of t he sit uat i on b y tele p h o ne or e mail.
F a x Seri o us A d verse E ve nts t o:
I n di a: 
T he G S K C H St u d y  Ma na ger will be res p o nsi ble f or f or war di n g t he S A E f or m t o t he 
Case Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d P ha mac o vi gila n ce, t he Me dical 
Di rect or res p o nsi ble f or t he st u d y a n d ot her G S K C H pers o n nel as a p pr o priate via 
e mail.
T he i nit ial re p ort will be f oll owe d u p wi t h more i nf or m at i on as rele va nt, or as 
re q ueste d b y t he G S K C H st u d y ma na ger.
7. 5 . F oll o w -u p of A d verse E ve nt s a n d Seri o us A d verse E ve nt s
F oll o w -u p of A Es a n d S A Es:

After t he i nit ial re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll ow u p 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 7 of 1 2 2
P P D

wi t h eac h s u bject a n d pr o vi de f urt her i nf or mati on o n t he s u bject’s c o n dit i on.

All A Es/ S A Es wil l be f oll owe d u nt il res ol uti on, u ntil t he c o n dit i on sta bili ses, 
u nt il t he e ve nt is ot her wise e x plai ne d, or u ntil t he s u bject is l ost t o f oll o w-u p.  

T he i n vest i gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of 
s u p ple me ntal meas ure me nts a n d/ or e va l uati ons as ma y be i n dicate d or as 
re q ueste d b y G S K t o eluci date as f ull y  as p ossi ble t he nat ure a n d/ or ca usality 
of  t he A E or S A E.

I n vesti gat ors are n ot o bli ge d t o acti vel y see k A Es or S A Es i n f or mer 
parti ci pa nts.  H o we ver, if t he i n vesti gat or lear ns of an y S A E, i ncl u di n g t he 
deat h, at a n y  ti me after a s u bject has bee n disc har ge d fr o m t he st u d y, a n d 
c o nsi ders t he e ve nt reas o na bl y relate d t o t he i n vesti gat i onal pr o d uct or st u d y  
parti ci pat i on, t he i n vest i gat or will pr om ptl y n otif y G S K C H.

T he i n vest i gat or will s u b mit a n y u p date d S A E data t o G S K wit hi n t he 
desi g nate d re p orti n g ti me fra mes.
Re g ul at or y a n d et hics re p orti n g re q uire me nts f or S A Es:

T he i n vest i gat or will pr om pt l y re p ort all S A Es t o G S K C H withi n t he 
desi g nate d re p orti n g ti mefra mes ( wit hi n 2 4 h o urs of  lear ni n g of t he e ve nt).  
G S K C H has a le gal res p o nsi bilit y t o n otif y, as a p pr o priate, t he lo c al  
re g ulat or y a ut h orit y a n d ot her re g ulat or y a ut h orities a b o ut t he safet y of a 
pr o d uct u n der cli nical i n vesti gati o n.  Pr o m pt n otificati o n of S A Es b y t he 
i n vesti gat or t o G S K C H is esse ntial s o t hat le gal o bli gati ons a n d et hical 
res p o nsi bilities t o war ds t he safety of  parti ci pa nts are met.

G S K C H will c o m p l y wit h c o u ntr y s pecific re g ulat or y re q uire me nts relati n g t o 
safety re p orti n g t o t he re g ulat or y a ut h orit y, I R B/I E C a n d i n vest i gat ors.

I n vesti gat or safety re p orts are pre pare d acc or di n g t o G S K C H p olic y a n d are 
f or war de d t o i n vesti gat ors as necessar y.  A n i n vesti gat or safet y re p ort is 
pre pare d f or a S A E(s) t hat is b ot h attri b uta ble t o i n vesti gati o nal pr o d uct a n d 
u ne x pect e d.  T he p ur p ose of t he re p ort is t o f ulfill s pecific re g ulat or y a n d 
G C P re q uire me nts, re gar di n g t he pr o d uct u n der i n vesti gati o n.

A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y re p ort descri bi n g a S A E(s) 
or ot her s pecific safet y i nf or mati on (e. g., s u m mar y of list i n g of S A Es) fr om 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 8 of 1 2 2

G S K C H will file it wit h t he I n vest i gat or Br oc h ure ( or safety state me nt) a n d 
will n otif y  t he I R B or I E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
8 . D A T A M A N A G E M E N T
F or t hi s st u d y, s u bject data will be e ntere d i nt o a n electr o nic case re p ort f or m, usi n g a 
G S K C H vali date d data s y st e m.
8 . 1. S o urce D oc u me nts/ D at a
T he s o urce d oc u me nts (e. g. h os pital rec or ds, cli nical a n d office c harts, la b orat or y  
n otes, m e mora n da, parti cipa nts ’ diaries or e val uati o n c hec klists, p har mac y dis pe nsi n g 
rec or ds, rec or de d data fr o m a ut o mate d i nstr u me nts, micr ofic hes, p h ot o gra p hic 
ne gat i ves, micr ofil m or ma g netic me dia, x-ra ys, s u bject files a n d rec or ds ke pt at t he 
p har mac y, at t he la b orat or y  a n d at t he me dic o -tec h nical de part me nts i n v ol ve d i n t he 
cli nical st u d y) w hic h c o ntai n t he s o urce of data rec or de d i n t he C R F s h o ul d be 
s pecifie d i n t he S o urce D oc u me nt Desi g nati on F or m.  I n s o me cases t he C R F ca n be 
use d as a s o urce d oc u me nt.
Eac h s u bject will be assi g ne d a n d i de nt ifie d b y a u ni q ue Scree ni n g N u m ber. A n y 
refere nce ma de t o a n i n di vi d ual s u bject wit hi n t he st u d y m ust be d o ne usi n g t he 
u ni q ue Scree ni n g N u m ber.
8. 2 . Electr o nic C ase Re p ort F or m
A C R F is a pri nte d, o ptical, or electr o nic d oc u me nt de sig ne d t o rec or d all of t he 
pr ot oc ol  r e q uire d i nf or mat i on t o be re p orte d t o t he s p o ns or o n eac h trial s u bject.
F or eac h s u bject w h o has gi ve n i nf or me d c o nse nt/asse nt a n d has bee n scree ne d, C R F 
m ust be c o m plete d a n d si g ne d b y t he Pri nci pal I n vesti gat or ( or a ut hori se d desi g nee) 
t o certif y t hat t he data are c o mplete a n d c orrect.  
Ma na ge me nt of cli nical data will be perf or me d i n acc or da nce wit h a p plica ble 
G S K C H sta n da rds a n d data clea ni n g pr oce d ures t o e ns ure t he i nte grit y  of t he data e. g. 
r e mo vi n g err ors a n d i nc o nsiste ncies i n t he data. 
I n or der t o pr otect t he pri vac y of part ici pa nts, n o Pers o nall y I de ntifia ble I nf or mati o n 
( PII) (incl u di n g t he s u bject's na me or i nit ials or birt h date) is t o be rec or de d i n t he 
C R F or as part of t he q uer y  te xt.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 7 9 of 1 2 2

A d verse e ve nts a n d c o nc o mit a nt me dicat i ons ter ms (if a p plica ble) will be c o de d 
usi n g Me d D R A ( Me dical Dicti o nar y  for Re g ul at or y A cti vities) a n d a n i nter nal 
vali date d m e dicat i on di ct i onar y, G S K Dr u g.  
S u bject data will be e ntere d i nt o G S K C H defi ne d C R Fs a n d tra ns mitte d elec tr o nicall y 
t o G S K C H i n a vali date d ( 2 1 C F R Part 1 1 c o m plia nt) we b-base d electr o nic data 
ca pt ure s yste m (I n F or m T M ).
All C R F pa ges s h o ul d be c o m plete d d uri n g a s u bject assess me nt w he n t he C R F has 
bee n desi g nate d as t he s o urce.  Data t hat is s o urce d else w here s h o uld be e ntere d i nt o 
t he C R F i n a n a gree d u p o n ti mefra me bet wee n t he I n vesti gat or a n d S p o ns or.  
T he C R Fs (i ncl u di n g q ueries, q uer y  res p o nses a n d a u dit trails) will be retai ne d b y 
G S K C H. Site data arc hi ve d c o m pact discs ( C D(s)) pre pare d b y  a t hir d part y will be 
se nt t o t he i n vesti gat or t o mai ntai n as t he i n vesti gat or c o p y fol l owi n g t he 
dec o m missi o ni n g of t he st u d y .
8. 3 . D at a H a n dli n g
D oc u m e nt atio n of  all d at a ma na ge me nt acti vit ies s h o ul d all o w ste p- b y-ste p 
retr os pecti ve assess me nt of data q uality a n d st u d y  perf or ma nce. A n y c ha n ges or 
c orrectio ns t o data will be perf or me d i n t he Electr o nic Data Ca pt ure ( E D C) S y st e m, 
a n d it will i ncl u de rati o nale f or c ha n ges. T he E D C s yste m has a n a u dit trail, w hic h 
will pr o vi de a c o m plete rec or d of t he c ha n ges a n d c orrecti o ns e n d orse d b y t he 
I n vesti gat or.
8. 3. 1 . D at a Q ueries
Pr o gra m me d e dit c hec ks will be ge nerate d a ut o maticall y , as t he data is bei n g e ntere d 
i nto t he s yste m . Data Ma na ge me nt will als o r u n re p orts a n d listi n gs o n t he C R F data, 
i n a d ditio n t o t he q ueries alrea d y  pr o gra m me d a n d ge nerate d b y t he s yste m, t o r aise 
ma n ual q ueries as nee de d f or site clarificat i on or c orrecti o n. T he Cli nical Dicti o nar y  
De vel o p me nt a n d Ma na ge me nt Gr o u p will raise q ueries as nee de d o n safet y data t o 
c o de t he ter ms ( A d verse E ve nts a n d Dr u gs) are re p orte d a p pr o pri atel y. 
T he st u d y  mo ni t or at t he st u d y sit e will re vie w t he C R Fs i n acc or da nce wit h t he 
m o nit ori n g pla n, a n d a n y  q ueries will be ge nerate d i n t he E D C S yst e m t o t he 
I n vesti gat or or desi g nee, e na bli n g t he err ors t o be a d dresse d i n parallel with Data 
Ma na g e me nt re vie w. M o nit or ca n als o r u n re p orts a n d listi n gs o n t he C R Fs, t o raise 
ma n ual q ueries as nee de d f or site clarificat i on or c orrecti o n
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 0 of 1 2 2

8. 4. Pr ocessi n g P atie nt Re p orte d O utc o mes
P ati e nt re p orte d o utc o me ( P R O) data are c ollecte d direct l y fr om t he s u bject P R O 
meas ures e. g. diar y car ds, q uesti o n naires etc, a n d e ntere d i nt o t he s p o ns or’s cli nical 
data m a na ge me nt s yste m ( D M S) b y t he st u d y site re prese ntati ve. I n i nsta nces w here 
t he P R O data is e ntere d i nt o t he D M S b y  G S K C H, t he P R Os will be a n o n y mise d, a n d 
f or war de d t o G S K C H f or e ntr y, as a gree d a n d d oc u me nte d a hea d of t he st u d y 
starti n g. P R Os t hat are s o urce will be retai ne d b y t he i n vesti gat or a n d certifie d c o pies 
will be se nt t o G S K C H. 
I n or der t o pr otect t he pri vac y of part ici pa nts, n o Pers o nall y I de ntifia ble I nf or mati o n 
( PII) (incl u di n g t he s u bject's na me or i nit ials or birt h date) is t o be rec or de d o n all 
P R O’s t hat will be f or war de d t o G S K C H.
8. 5. E xter n al D at a
E xter nal Data are s u bject data o btai ne d e xter nall y  t o t he C R F. T hese data are 
ge nerate d fr o m la b orat or y instr u m e nts, c o mp uters or ot her s o urces a n d t he n 
tra nscri be d i nt o a file a n d f or mat a gree d u p o n b y G S K C H t o ide nt if y t he s u bject a n d 
ti me p oi nt refere nce d i n t he C R F a n d/ or pr ot oc ol. 
A n a gree d u p o n q ualit y c o ntr ol pr ocess is perf or me d a gai nst t he tra nscri be d data t o 
t he s o urce t o e ns ure t he acc urac y of t he tra nscript i o n. T he tra nscri be d data is 
tra ns mitte d i n a n a gree d u p o n f or mat t o G S K C H via sec ure d we b p ortal or C D/ D V D 
via mail carrier wit h trac ki n g ca pa bilit ies. 
Pr o per rec o nciliat i on will be perf or me d bet wee n t he tra nscri be d data a n d t he cli nical 
data base t o e ns ure s u bject a n d ti me p oi nt refere nce d i n t he Cli nical Data base matc h 
bef ore Cli nical Data base Freeze (l oc ki n g of t he data base) ca n occ ur.
9. S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A 
A N A L Y S E S
9 . 1 S a m ple Size Deter mi n ati o n
T he pri mar y  efficac y v aria bl e of t he st u d y is t he t otal n u m ber of ill da ys d ue t o GI
a n d res pirat or y ill nesses. T he sa m ple size has bee n calc ulate d base d o n t he 
ass u m pt i on of a n a ve r a g e of 7 ill da ys i n t he c o ntr ol gr o u p wit h a differe nce of 1 0 % 
bet wee n t he treat me nts.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 1 of 1 2 2

Years L ost d ue t o Di sa bilit y ( Y L D) is a meas ure of t he b ur de n of disease fr o m its 
m o r bidi t y. B elo w are data t hat are s pecific t o I n dia: As per t he data fr o m Gl o bal 
B ur de n Disease, W H O 2 0 1 0 st u d y  ( G B D, W H O, 2 0 1 2; I H M E, 2 0 1 3) a n d Ce ns us 
I n dia, 2 0 1 1, Y L D per c hil d i n t he 5 -9 y ear a ge gr o u p, d ue t o diarr hea, L R TIs, ot her 
i nfecti ous di sease a n d n utritio n al  deficie ncies is 8. 2 7 4 da ys/c hil d per year or 6. 2 1 
da ys/c hil d per 9 m o nt hs.
T h us, base d o n a b o ve data, a p pr o xi matel y  7 ill da ys d ue t o GI a n d res pirat or y 
ill nesses p er 9 m o nt hs has bee n ass u me d i n t his pr o p ose d st u d y  p o p ulat i on of 7 - 1 0 
year ol ds. 
T he sa m ple size is base d o n t he pri mar y e n d p o i nt. N o sa m ple size c o nsi derati o ns 
ha ve bee n ta ke n i nt o acc o u nt f or sec o n dar y  o bjecti ves.
T he si m ulate d data were als o use d base d u p o n t he ass u m pt i on of a P oiss o n 
di stri b uti on per st u d y  treat me nt. O n o bser vat i on of t hese si m ulate d data, it was 
c o nsi dere d t hat t hese P oiss o n distri b uti o ns w ere n ot hea vil y s ke we d a n d, as a res ult, 
n or m al distri b uti ons ma y be ass u me d. C o nse q ue nt l y, a n or mality ass u m pti o n has 
bee n a d o pte d f or b ot h t he ge nerati o n of sa m ple size a n d t he i nte n de d a p pr oac h t o t he 
statistical a nal ysis.
Beca use of ass u m pt i on of p oiss o n distri b uti o n, est i mates of varia bility were 
calc ulate d as s q uare r o ot of mea n.
Mea n of c o ntr ol was ass u me d t o be 7. 0 a n d sta n dar d de viat i on ( S D) was 2. 6 5, mea n 
of  test gr o u p was 6. 3 a n d S D was 2. 5 1. T o be a ble t o ac hie ve 8 0 % p o wer, 2 1 5 
parti ci pa nts per treat me nt ar m ( T otal = 4 3 0) will be re q uire d t o c o m plete t he st u d y in 
case of i n di vi d ual ra n d o misat i on. T his ass u mes 5 % le vel of si g nifica nce (t w o taile d t -
test).
As t hi s st u d y is usi n g cl uster ra n d o misat i on, a n d desi g n effect ( D E) nee ds t o be 
c o nsi dere d for sa m ple size calc ulati o ns. Scie nt ific literat ure s u g gests, D E d ue t o 
cluster sa m pli n g strate g y  ca n be ass u me d t o be 1. 5 [ R os ner, B, 1 9 8 6]. Sa me has bee n 
ass u me d i n o ne st u d y, w hic h use d t hree-sta ge s yste matic cl uster sa m pli n g [ Da n d o na 
R et al, 2 0 0 8]. 
Us i n g t he f oll owi n g f or m ul a f r o m He m mi n g et al, 2 0 1 1:
N * = N x D E
W here N * = N u m ber of partici pa nts re q uire d f or cl uster ra n d o mise d trial
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 2 of 1 2 2

N = N u m ber of partici pa nts re q uire d f or i n di vi d ual ra n d o misat i on 
D E = Desi g n Effect
A n d ass u mi n g D E t o be 1. 5, t he n u m be r of e val ua ble partici pa nts c o mplet i n g t he 
st u d y r e q uir e d w o uld be 3 2 3 per ar m  ( T otal= 6 4 6).
T o all o w f or 3 0 % dr o p -o ut rate, a t otal of 9 2 4 partici pa nts will be ra n d o mise d.
A p pr o xi matel y  1 3 0 0 parti ci pa nts will be scree ne d t o ra n d o mise a p pr o xi matel y 9 2 4 
part ici pa nts i n or der t o o btai n 6 4 6 partici pa nts c o m pleti n g t he st u d y.
9. 2. Ge ner al C o nsi der ati o ns
9. 2. 1. Defi niti o n of A n al ysis P o p ul ati o ns
All partici pa nts w h o recei ve t he st u d y pr o d uct will be c o nsi dere d e val ua ble f or t he 
safety p o p ul at i on. 
All partici pa nts i n t he safet y  p o p ulat i on wi t h a n y p ost-treat me nt assess me nt will be 
i ncl u de d i n I nte nt-t o-treat (I T T) p o p ulati o n. I T T p o p ulati on will be t he pri mar y 
p o p ul at i on f or efficac y a nal ysis.
P er pr ot oc ol ( P P) p o p ulati o n will c o nsist of partici pa nts w h o ha ve all p ost -treat me nt 
assess me nts a n d d o n ot ha ve a n y  pr ot oc ol viol at i ons t hat w o ul d affect efficac y 
assess me nts. P P a nal yses will be perf or m e d o nl y if t here is m o re t ha n 5 % differe nce 
bet wee n n u m ber of st u d y p artici pa nts i n I T T a n d P P p o p ulati on. A fi nal decisi o n o n 
w het her a P P a nal ysis will be perf or me d will be ma de pri or t o s t u d y u n-bli n di n g.
9. 2. 2. E xcl usi o n of D at a fr o m A n al ysis
Pri or t o data base l oc k a n d brea ki n g of t he st u d y bli n d, re vie w list i n gs will be defi ne d 
a n d re vie we d b y t he Bi ostatist icia n a n d Me dical Direct or ( or desi g nee) t o i de ntif y 
pr ot oc ol  viol at i ons a n d t o deter mi ne t heir le vel o f i m pact o n efficac y a nal yses. 
F urt her deta ils of t hese re vie w listi n gs will be pr o vi de d i n t he statistical a nal ysis pla n 
( S A P) a n d re vie w listi n g s pecificati on d oc u me nt. T he re vie w list i n gs ma y i ncl u de, 
b ut will n ot be necessaril y  li mite d t o, t he f oll o wi n g:

Vi ol at i on of i ncl usi o n or e xcl usi o n cri teria t hat are dee me d t o affect efficac y.

Use of pr o hi bite d treat me nt (e. g. usa ge of  i m m u n os u p pressi ve t hera p y e. g., 
or al  c ortic oster oids or c he m ot h era p y d uri n g t he c o urse of  st u d y) or me dicat i on 
bef ore or d uri n g t he st u d y , w hic h is felt t o affect t he assess me nt of efficac y. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 3 of 1 2 2


N o n -c o mplia nce wi t h pr o d uct a d mi nistrati o n.

C o m me nts.
9. 2. 3. Criteri a f or Assessi n g Effic ac y
T he st u d y  will b e d e e me d t o be s uccessf ul if a statisticall y si g nifica nt decrease is 
d e m o nstrate d i n n u m ber of ill da ys d uri n g ni ne ( 9) m o nt hs of i nter ve nti o n i n t he test 
pr o d uct gr o u p c o m pare d t o t he c o ntr ol pr o d uct of t he st u d y .
9. 2. 4. Criteri a f or Assessi n g T oler a bilit y
S af et y will be assesse d b y re p orti n g a d verse e ve nts ( A Es) b y  all p arti ci pa nts ta ki n g 
t he test pr o d uct vs. c o ntr ol pr o d uct of t he st u d y .
9. 2. 5. H a n dli n g of Dr o p o uts a n d Missi n g D at a
N o data will be i m p ute d i n case of dr o p o uts or missi n g data.
9. 2. 6. Ot her Iss ues
T here will be n o i nteri m a nal ysis.
9 . 3. St atistic al Met h o ds a n d A n al ytic al Pl a n
A d di tio n al details of t he pr o pose d statistical a nal ysis will be d oc u me nte d i n t he 
statistical a nal ysis pla n ( S A P), w hic h will be writte n f o ll owi n g fi nal isat i on of t he 
pr ot oc ol a n d pri or t o S T U D Y A N A L Y SI S stu d y start (first s u bject first visit 
( F S F V)).
9 . 3.1. De m o gr a p hic a n d B aseli ne C h ar acteristics
P arti cipa nt de m o gra p hics i nf or m at i on will i ncl u de a ge, ge n der, a n d race.  
Baseli ne c haracterist ics will i ncl u de hei g ht, wei g ht, a n d H A Z .
Cate g orical meas ures ( ge n der, race, a n d H A Z (f or ra n ges: -3 t o -2 a n d -2 t o - 1)) will 
be s u m mari se d b y n u m ber a n d perce nt of partici pa nts i n eac h cate g or y .  
Descri pt i ve statistics f or c o nti n u o us meas ures (a ge, heig ht, wei g ht, B MI a n d H A Z ) 
will i ncl u de t he n u m ber of partici pa nts ( N), mea n, me dia n, sta n dar d de viat i on ( S D), 
mi ni m u m, a n d ma xi m u m.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 4 of 1 2 2

9 . 3.2. Pri m ar y A n al yses
T he pri mar y  efficac y v aria bl e of t he st u d y is t he n u m ber of ill da ys. T he n u m ber of ill 
da ys i s defi ne d as n u m ber of da ys a s u bject is ill beca use of GI a n d/ or res pirat or y 
ill nesses as dia g n ose d b y st u d y p h ysicia n, as per t he crit eria defi ne d i n Secti o n 6. 1 1. 1 
a n d 6. 1 1. 2, o ver t he i nter ve nt i on p eri o d. 
F or t hi s varia ble, pri mar y a nal ysis will be perf or me d o n partici pa nts i n I T T 
p o p ul at i on w h o ha ve c o m p lete d t he e ntire st u d y for 9 m o nt hs. 
T he n ull h y p ot hesis of i nterest is:
H 0: T here is n o differe nce i n t he n u m ber of ill da ys .
T he al ter nati ve h y p ot hesis of i nterest is:
H 1: T here is a differe nce i n t he n u m ber of ill da ys.
T he n u m ber of ill da ys will be s u m marise d i n ter ms of n u m ber ( N), mea n, sta n dar d 
de viat i on, mi ni m u m, a n d ma xi m u m f or b ot h t he treat me nt gr o u ps.
T he n u m ber of ill da ys will be a n al yse d usi n g t he a nal ysis o f varia nce ( A N O V A). 
T he A N O V A will ha ve treat me nt, cl u ster (sc h o ol), a n d ge n der as fi xe d effects. 
A d j uste d mea ns, 9 5 % c o nfi de nce i nter vals, wit hi n treat me nt p-val ues f or eac h 
treat me nt gr o u p, treat me nt gr o u p differe nce, 9 5 % c o nfi de nce i nter val o f t he 
differe nce a n d t he bet wee n -treat me nt p-val ues base d o n t he statistical m o del 
descri be d a b o ve will als o be prese nte d. 
All st atistical tests of h y p ot heses will be t w o-side d a n d will e m pl o y a le vel of 
sig nifica nce of α = 0. 0 5.  
T he si m ulate d data use d f or t he sa m ple size calc ulati o ns were base d u p o n t he 
ass u mpt i on of a P oiss o n distri b ut i on per st u d y  treat me nt.   H o we ver, o n o bser vati o n of
t hese si m ulate d data, it was c o nsi dere d t hat t hese P oiss o n distri b ut i ons were n ot 
hea vil y s ke we d a n d, as a res ult, n or mal distri b ut i ons ma y be ass u me d.   C o nse q ue nt l y, 
a n or mality ass u m pti o n has bee n a d o pte d f or b ot h t he ge nerat i on of sa m ple size a n d 
t he i nte n de d a p pr oac h t o t he statistical a nal ysis.   H o we ver, t he ass u m pti o ns of 
n or m alit y a n d h o m o ge neit y of  varia nce will be i n vesti gate d a n d vi olati on of t hese 
ass u m pt i ons ma y be o verc o me usi n g s uita ble tra nsf or mat i on (f or e xa m ple, l o g or 
s q uare r o ot).  If tra nsf or me d data is als o n o n-n or mal, t he n alter nati ve a nal yses 
r ele va nt t o P oiss o n distri b ute d data will be i n vesti gate d (f urt her details will be 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 5 of 1 2 2

pr o vi de d i n t he S A P).   If n o ne of t hese o ptio ns are c o nsi dere d a p pr o priate f or t he 
data, t he n a p pr o priate n o n- para metri c tests will be perf or me d.
9 . 3.3. Sec o n d ar y A n al ys es
F o ll owi n g sec o n dar y  efficac y varia bles will be a nal yse d f or b ot h c o m pleters (t h ose 
w h o c o m plete d e nti r e 9 mo nt hs of st u d y ) a n d I T T p o p ulat i on.
T he sec o n dar y  efficac y varia bles are:

Fre q ue nc y of GI a n d res pirat or y ill nesses defi ne d as t otal n u m ber of ill ness 
e pis o des of  GI a n d/ or res pirat or y ill nesses, di vi de d b y  d urat i on of i nter ve nt i on, 
w here eac h e pis o de is defi ne d as eac h i nci de nce of ill ness f o ll owe d b y  at least 3 
s y m pto m  free da ys ( Secti on 6. 1 1. 2 ).
T he sa me m o del o utli ne d a b o ve f or pri mar y  o utc o me varia ble will be use d f or t his 
sec o n dar y o ut c o me. 

Se verit y of GI a n d res pirat or y ill nesses (Mil d, m o derate, or se vere i nte nsit y as 
ca pt ure d i n D F ) ( See Secti o n 6. 1 1. 2 f or details o n ca pt uri n g se verit y of  ill ness).
T his will be will be ca pt ure d b y  st u d y p h ysicia n as per se verity gra di n g o utli ne d 
i n A p pe n di x 5 . Fre q uencies of i nte nsit y ( Mil d, mo derate, or se vere) b y treat me nt 
gr o u ps will be c o m pare d usi n g c hi -s q uare test (if fre q ue ncies are greater t ha n 
5 %). If fre q ue ncies are ≤ 5 % i n a n y treat me nt gr o u ps, t he n t hese will be c o m pare d 
usi n g Fis her’s e xact test bet wee n t reat me nt gr o u ps. 

Sc h o ol  a bse nteeis m d ue t o GI a n d res pirat or y ill nesses as ide nt ifie d fr o m D F . 
T he sa me m o del o utli ne d a b o ve f or pri mar y  o utc o me varia ble will be use d f or t his 
sec o n dar y o ut c o me.

C ha n ge fr o m baseli ne ( meas ure d at scree ni n g visit ) i n B MI.
T his will be a nal yse d usi n g a n a nal ysis of c o varia nce ( A N C O V A) m o del. T he 
m o d el  will i ncl u de t he fi xe d fact ors f or treat me nt, cluster (sc h o ol ) a n d ge n der ; 
baseli ne B MI assess me nt rec or de d at  scree ni n g visit as c o variate. 

C ha n ge fr o m baseli ne i n g ut i nte gri t y/ h e alt h as meas ure d b y La ct ulose: Ma n nit ol  
test a n d Uri nar y Ne o pteri n test defi ne d i n Sect i on 6. 9. 1. 1 res pecti vel y. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 6 of 1 2 2

T hese will be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he 
fi xe d fact ors f or treat me nt, cl u ster (sc h o ol) a n d ge n der ; baseli ne g ut 
i nte grit y/ he alt h assess me nt at baseli ne as c o variate . 

C ha n ge fr o m baseli ne i n sali var y I g A as defi ne d i n Secti o n 6. 9. 1. 2.
T his will be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he fi xe d 
fact ors f or treat me nt , cl u ster (sc h o ol), a n d ge n der ; baseli ne sali var y  I g A 
assess me nt at baseli ne as c o variate.

C ha n ge fr o m baseli ne i n le vels of micr on utri e nts Vita mi n A, B 6, B 1 2, C, D ( 2 5 
H y dr o x y  c h ole calcifer ol), E, f olate, of t he trace ele me nts sele ni u m, zi nc, c o p per, 
a n d ir o n as deter mi ne d b y bl o o d dra w a n d a nal ysis ( Secti o n 6. 9. 1. 3). 
T hese will  be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he 
fi xe d fact ors f or treat me nt, cl u ster (sc h o ol) a n d ge n der ; baseli ne assess me nts at 
baseli ne as c o variate.

C ha n ge fr o m baseli ne i n le vels o f ferritin, ser u m tra nsferri n rece pt or (s Tf R), C-
reacti ve pr otei n ( C R P), a n d Al p ha 1-aci d gl yc o pr otei n ( A G P) as deter mi ne d b y 
bl o o d dra w a n d a nal ysis ( Sect i on 6. 9. 1. 3). 
T hese will be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he 
fi xe d fact ors f or treat me nt, cl uster (sc h o ol) a n d ge n der; baseli ne assess me nts at 
baseli ne as c o variate.

C ha n ge fr o m baseli ne i n dietar y  di versit y sc ore as assesse d t hr o u g h 2 4-h o ur 
I D D S ( Secti o n 6.1 2. 2 ). 
T hese will be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he 
fi xe d fact ors f or treat me nt, cl uster (sc h o ol) a n d ge n der; baseli ne assess me nts at 
scree ni n g as c o variate.

C ha n ge fr o m baseli ne i n e ner g y, pr otei n, car b o h y drate a n d fat fr o m 2 4-h o ur 
di et ar y recall s ur ve y ( Sectio n 6. 1 2. 1 ). 
T hese will be a nal yse d usi n g a n A N C O V A m o del. T he m o del will i ncl u de t he 
fi xe d fact ors f or treat me nt, cl uster (sc h o ol) a n d ge n der; baseli ne assess me nts at 
scree ni n g as c o variate.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 7 of 1 2 2

A d j uste d mea ns, 9 5 % c o nfi de nce i nter vals, wit hi n treat me nt p-val ues f or eac h 
treat me nt gr o u p, treat me nt gr o u p differe nce, 9 5 % c o nfi de nce i nter val of t he 
differe nce a n d t he bet wee n- treat me nt p-val ues base d o n t he statistical m o del 
descri be d a b o ve f or eac h sec o n dar y  o ut c o me will als o be prese nte d.
All st atistical tests of h y p ot heses will be t w o-side d a n d will e m pl o y a le vel of 
sig nifica nce o f α = 0. 0 5.  
T he ass u m pt i ons o f n or m alit y a n d h o mo ge nei t y of varia nce will be i n vesti gate d.  
Vi ol at i on of t hese ass u m pti o ns ma y be o verc o me usi n g s uita ble tra nsf or mat i on (f or 
e xa m ple, l o g) or perf or mi n g a p pr o priate n o n- para metri c tests.
9 . 3.4. S afet y A n al ys es
All p arti ci pa nts w h o recei ve treat me nt will be i ncl u de d i n t he safet y a nal ysis a n d 
re p orti n g of safety data. A Es (i ncl u di n g se verit y/relat i ons hi p t o st u d y  tr e at me nt) will 
be s u m marise d b y  tr e at me nt gr o u p. A Es re p orte d pri or t o pr o d uc t a d mi nistrati o n will 
be re gar de d as pre -treat me nt a n d will be i ncl u de d i n A E data listi n g. A Es will be 
re gar de d as treat me nt e mer ge nt if t he y occ ur d uri n g or after t he first d ose of pr o d uct 
a d mi nistrati o n (i.e. + 1 t o 3 da ys p ost ra n d o misat i on at Baseli ne Visi t.
9. 3. 5 Ot her A n al yses
As e x pl orat or y  a nal ysis, f oll owi n g a nal yses will als o be perf or me d :

A nal ysis o n n u m ber of ill da ys will be perf or m e d f or t h ose partici pa nts i n I T T 
p o p ul at i on w h o ha ve c o m p lete d t he st u d y for 3 m o nt hs a n d 6 m o nt hs 
se paratel y.

A na l ysis o n n u m ber of ill da ys will be perf or m e d o n GI a n d res pirat or y 
ill nesses se paratel y o n t h ose partici pa nts w h o are i n I T T p o p ulat i on a n d ha ve 
c o mplete d t he st u d y  for 3 m o nt hs, 6 m o nt hs a n d 9 m o nt hs.

T ot al  nu m ber of ill da ys (GI a n d res pirat or y ill nesses), n u m ber of e pis o des
(GI a n d res pirat or y ill nesses) , a n d se verit y of  GI a n d res pirat or y ill nesses b y 
ge n der will als o be a nal yse d.

T ot al  n u m ber of ill da ys (GI a n d res pirat or y ill nesses), n u m ber of e pis o des 
(GI a n d res pirat or y ill nesses), a n d se verit y of  GI a n d res pirat or y ill nesses b y 
scree ni n g, e n d of st u d y, a n d c ha n ge fr o m baseli ne i n D D S, e ner g y, pr otei n, 
car b o h y drate a n d fat will als o be a nal yse d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 8 of 1 2 2

T he sa me m o del o utli ne d a b o ve f or pri mar y o utc o me varia ble ( Secti on 9. 3. 2) will be 
use d f or t his sec o n dar y o ut c o m e.
A d j uste d mea ns, 9 5 % c o nfi de nce i nter vals, wit hi n treat me nt p-val ues f or eac h 
treat me nt gr o u p, treat me nt gr o u p differe nce, 9 5 % c o nfi de nce i nter val o f t he 
differe nce a n d t he bet wee n- treat me nt p-val ues base d o n t he statistical m o del 
descri be d a b o ve f or eac h sec o n dar y o ut c o me will als o be prese nte d.
All st atistical tests of h y p ot heses will be t w o-side d a n d will e m pl o y a le vel of 
sig nifica nce of α = 0. 0 5.  
T he ass u m pt i ons o f n or m alit y a n d h o mo ge nei t y of varia nce will be i n vesti gate d.  
Vi ol at i on of t h ese ass u m pti o ns ma y be o verc o me usi n g s uita ble tra nsf or mat i on (f or 
e xa m ple, l o g) or perf or mi n g a p pr o priate n o n- para metri c tests.
1 0 . S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S
1 0 . 1. P osti n g of I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als 
Re gisters
St u d y  inf or m at i on fr om t his pr ot oc ol will be p oste d o n p u blicl y a vaila ble cli nical trial 
r e gisters bef ore e nr oll me nt of p artici pa nts be gi ns.
1 0. 2. Re g ul at or y a n d Et hic al C o nsi der ati o ns, I ncl u di n g t he I nf or me d 
C o nse nt
T he st u d y  will be c o n d ucte d i n acc or da nce wit h all a p plica ble re g ulat or y 
re q uire me nts, a n d wit h G S K / D E SI G N A T E D C R O p olic y .
T he st u d y  will als o be c o n d ucte d i n acc or da nce wit h I C H G o o d Cli nical Pract ice 
( G C P), all a p plica ble s u bject pri vac y re q uire me nts, a n d t he g ui di n g pri nci ples of t he 
c urre nt versi o n of t he Declarat i on of Helsi n ki.  T his i ncl u des, b u t is n ot li mite d t o, t he 
f oll owi n g:

Bef ore i nit iati n g a trial, t he i n vesti gat or/i nstit uti o n s h o ul d ha ve writte n a n d 
date d a p pr o val/fa v ora ble o pi ni o n fr o m t he I R B/I E C f or t he trial pr ot oc ol 
(incl u di n g a me n d me nts), writte n i nf or me d c o nse nt f or m, c o nse nt f or m 
u p dates, s u bject recr uit me nt  pr oce d ures (e. g., a d vertise me nts), i n vesti gat or 
br oc h ure/ safet y  state me nt (i ncl u di n g a n y u p dates) a n d a n y ot her writte n 
i nf or mat i on t o be pr o vi de d t o partici pa nts . A letter or certificate of a p pr o val 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 8 9 of 1 2 2

will be se nt b y  t he i n vestigat or t o t he s p o ns or pri or t o i nit iati o n of t he st u d y, 
a n d als o w he n s u bse q ue nt a me n d me nts t o t he pr ot oc ol are ma de.

Si g ne d i nf or me d c o nse nt t o be o btai ne d f or eac h s u bject’s pare nt/ L A R a n d 
sig ne d asse nt t o be o btai ne d fr o m eac h s u bject. I n vesti gat or rep orti n g 
re q uire me nts (e. g. re p orti n g of A Es/ S A Es/ pr ot oc ol de viati ons t o I R B/I E C)

G S K will pr o vi de f ull details o f t he a b o ve pr oce d ures, eit her ver ball y, i n 
wri ti n g, or b ot h.
1 0. 3. Q u alit y C o ntr ol ( St u d y M o nit ori n g)
I n acc or da nce wit h a p plica ble re g ulati o ns i ncl u di n g G C P, a n d G S K/ D E SI G N A T E D 
C R O pr oce d ures, G S K or desi g nee (i.e. t hir d part y ve n d or) m o nit ors will c o ntact t he 
sit e prior t o t he start of t he st u d y  t o re vie w wit h t h e site staff t he pr ot oc ol, st u d y 
re q uire me nts, a n d t heir res p o nsi bilities t o satisf y re g ulat or y, et hical, a n d G S K
A N D/ O R C R O re q uire me nts.
W he n re vie wi n g da ta c ollecti on pr oce d ures, t he disc ussi o n will i ncl u de i de nt ificati o n, 
a gree me nt a n d d oc u me ntatio n of  data it e ms for w hic h t he C R F will ser ve as t he 
s o urce d oc u me nt.
G S K or desi g nee will m o nit or t he st u d y  a n d site acti vit y t o verif y t hat t he:

Data are a ut he nt ic, acc urate, a n d c o m plete.

S af et y a n d rig hts of  parti ci pa nts are bei n g pr otecte d.

St u d y  is c o n d ucte d i n acc or da nce wit h t he c urre nt l y a p pr o ve d pr ot oc ol a n d 
a n y ot her st u d y a gree me nts, G C P, a n d all a p plica ble re g ulat or y re q uire me nts.
T he e xte nt a n d nat ur e of m o nit ori n g will be descri be d i n a writte n m o nit ori n g pla n o n 
file at G S K C H. T he i n vesti gat or ( or desi g nee) a grees t o all o w t he m o nit or direct 
access t o all rele va nt d oc u me nts a n d a grees t o c o- o perate wi t h t he mo ni t or t o e ns ure 
t hat a n y pr o ble ms detecte d i n t he c o urse of t hese m o nit ori n g visits are res ol ve d.
1 0. 4. Q u alit y Ass ur a nce
T o e ns ure c o m plia nce wit h G C P a n d all a p plica ble re g ulat or y  re q uire me nts, G S K 
ma y c o n d uct a q ualit y ass ura nce assess me nt a n d/ or a u dit of t he site rec or ds, a n d t he 
re g ulat or y a ge ncies ma y c o n d uct a re g ulat or y  ins pecti o n at a n y  time d uri n g or after 
c o mplet i on of t he st u d y . 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 0 of 1 2 2

I n t he e ve nt of a n assess me nt, a u dit or i ns pecti on, t he i n vest i gat or (a n d i nstitut i on) 
m ust a gree t o gra nt t he a d vis or(s), a u dit or(s) a n d i ns pect or(s) direct access t o all 
r ele va nt d oc u me nts a n d t o all ocate t heir ti me a n d t he ti me o f t heir staff t o disc uss t he 
c o n d uct of t he st u d y, a n y fi n di n gs/rele va nt iss ues a n d t o i m ple me nt a n y c orrective 
a n d/ or pre ve ntati ve act i ons t o a d dress a n y fi n di n gs/iss ues i de nt ifie d.
T he s p o ns or will be a vaila ble t o hel p i n vesti gat ors pre pare f or a n i ns pecti o n.
1 0. 5. C o n diti o ns f or Ter mi n ati n g t he St u d y
U p o n c o m plet i on or pre mat ure disc o nt i n uati on of t he st u d y , t he G S K C H m o nit or O R 
D E SI G N E E (I. E. T HI R D P A R T Y V E N D O R) will c o n d uct site clos ure acti vit ies 
wi t h t he i n vesti gat or or site staff, as a p pr o priate, i n acc or da nce wit h a p plica ble 
re g ulat i ons i ncl u di n g G C P, a n d G S K C H/ C R O Sta n dar d O perati n g Pr oce d ures.
B ot h G S K C H a n d t he I n vest i gat or reser ve t he ri g ht t o te m p oraril y s us pe n d or 
p r e mat urel y disc o nti n ue t his st u d y at a n y time f or reas o ns i ncl u di n g, b ut n ot li mite d 
t o, safety or et hi cal iss ues or se vere n o n-c o m p lia nce. F or m ultice nter st u dies (if 
a p plica ble), t his ca n occ ur at o ne or m ore or at all sites.  
If t he trial is pre mat urely ter mi nate d or s us pe n de d f or a n y reas o n, t he i n vesti gat or site 
s h o uld pr o m pt l y i nf or m t he trial partici p a nts a n d s h o ul d ass ure a p pr o priate t hera p y/ 
f oll ow -u p f or t he parti ci pa nts. W here re q uire d b y t he a p plica ble re g ulat or y 
re q uire me nts, G S K C H s h o ul d i nf or m t he re g ulat or y a ut h orit y (ies). 
I n a d diti on: 

If t he i n vesti gat or ter mi nates or s us pe n ds a trial wit h o ut pri or a gree me nt of 
G S K C H, t he i n vesti gat or site s h o ul d pr o m pt l y i nf or m t he s p o ns or a n d t he 
I R B/I E C, a n d s h o ul d pr o vi de t he s p o ns or a n d t he I R B/I EC a detaile d writte n 
e x pla nat i on of t he ter mi nat i on or s us pe nsi o n.

If t he G S K C H ter mi nates or s us pe n ds a trial, t he i n vesti gat or s h o ul d pr o m ptl y 
i nf or m t he I R B/I E C a n d pr o vi de t he I R B/I E C a detaile d writte n e x pla nat i on of 
t he ter mi nat i on or s us pe nsi o n. 

If t he I R B/I E C t er mi nates or s us pe n ds its a p pr o val/fa v ora ble o pi ni on of a tri al, 
t he i n vest i gat or s h o ul d pr o m ptl y n otif y t he G S K C H a n d pr o vi de G S K C H wit h 
a detaile d writte n e x pla nat i on of t he ter mi nati o n or s us pe nsi o n.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 1 of 1 2 2

1 0. 6. Rec or ds Rete nti o n
F o ll owi n g cl os ure of t h e st u d y, t he i n vesti gat or m ust mai ntai n all site st u d y rec or ds 
(e xce pt f or t h ose re q uire d b y l ocal re g ulati o ns t o be mai ntai ne d else w here), i n a safe 
a n d sec ure l ocati o n.  
T he rec or ds (st u d y / sit e master file) m ust be mai nt ai ne d t o all o w eas y a n d ti mel y 
retrie val, w he n nee de d (e. g., f or a G S K a u dit or re g ulat or y  ins pect i on) a n d m ust be 
a vaila ble f or re vie w i n c o nj u nct i on wi t h assess me nt of t he facility,  s u p p orti n g 
s yste ms, a n d rele va nt site staff.
W here per mitte d b y  lo c al  la ws/re g ulat i ons or i nstit uti o nal p olic y, s o m e or all of t hese 
rec or ds ca n be mai ntai ne d i n a f or mat ot her t ha n har d c o p y (e. g., micr ofic he, sca n ne d, 
ele ctr o nic); h o we ver, ca uti o n nee ds t o be e xercise d bef ore s uc h act i on is ta ke n. 
T he i n vest i gat or m ust e ns ure t hat all re pr o d ucti o ns are legi ble a n d are a tr ue a n d 
acc urate c o p y of t he origi nal  a nd m eet accessi bilit y a n d retrie val sta n dar ds, i ncl u di n g 
r e-ge nerati n g a har d c o p y , if re q uire d.  F urt her more, t he i n vest i gat or m ust e ns ure 
t here is a n acce pta ble bac k -u p of  t hese re pr o d ucti o ns a n d t hat a n acce pta ble q ualit y 
c o ntr ol pr ocess e xists f or ma ki n g t hese re pr o d ucti o ns.
T he i n vest i gat or m ust ass ure t hat t he s u bject’s a n o n y mity will  b e mai ntai ne d.  O n 
C R Fs or ot her d oc u me nts s u b mitte d t o G S K C H, partici pa nts s h o uld n ot be i de ntifie d 
b y t heir na m es or i nit ials, b ut b y a n ide ntificat i on c o de. T he i n vest i gat or s h o ul d kee p 
a se parate l o g of parti ci pa nts’ c o des, na mes a n d a d dresses.  D oc u me nts n ot f or 
s u b missi on t o G S K C H, e. g. partici pa nts ’ writte n c o nse nt f or ms, s h o ul d be mai ntai ne d 
b y t he i n vesti gat or i n stri ct c o nfi de nce.
G S K will i nf or m t he i n vest i gat or of t he ti me peri o d f or retai ni n g t hese rec or ds t o 
c o mpl y  wit h all a p plica ble re g ulat or y re q uire me nts ( G S K C H rec o m me n ds t hat 
d oc u m e nts be ke pt f or 1 0 years). T he i n vest i gat or is als o re q uire d t o kee p s u bject 
i de ntificati on c o des o n file f or at least 1 5 y ears aft er c o mpl et i on or di sc o nti n uati on of 
t he st u d y. T he mi ni m u m rete nti on ti me will meet t he strictest sta n dar d a p plica ble t o 
t hat sit e for t he st u d y , as dictate d b y a n y inst ituti o n al  re q uire me nts or l ocal la ws or 
re g ulat i ons, G S K sta n dar ds/ pr oce d ures, a n d/ or i nstit ut i onal re q uire me nts. 
N o st u d y  d oc u me nt s h o ul d be destr o ye d wit ho ut a pri or wri tte n a gree me nt bet wee n 
G S K C H a n d t he i n vest i gat or. T he i n vesti gat or m ust n otif y G S K of a n y c ha n ges i n t he 
ar c hi val arra n ge me nts, i ncl u di n g, b ut n ot li mite d t o, arc hi val at a n off-sit e facilit y or 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 2 of 1 2 2

tra nsfer of o w ners hi p of t he rec or ds i n t he e ve nt t he i n vesti gat or is n o l o n ger 
ass ociat e d wit h t he sit e.
1 0. 7. Pr o visi o n of St u d y Res ults t o I n vesti g at ors, p osti n g of 
I nfor m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als Re gisters 
a n d P u blic ati o n
W here re q uire d b y  a p plica ble re g ulat or y re q uire me nts, a n i n vesti gat or si g nat or y will 
be i de ntifie d f or t he a p pr o val of t he cli nical st u d y re p ort.  T he i n vesti gat or will be 
pr o vi de d reas o na ble access t o statist ical ta bles, fi g ures, a n d rele va nt re p orts a n d will 
ha ve t he o p p ort u nit y t o re vie w t he c o m plete st u d y res ults at a G S K site or ot her 
m u t uall y-a greea ble l ocati o n.
G S K will als o pr o vi de t he i n vest i gat or wit h t he f ull s u m mar y of t he st u d y res ults.  
T he i n vest i gat or is e nc o ura ge d t o s hare t he s u m mar y res ults wit h t he st u d y 
parti ci pa nts, as a p pr o priate.
T he pr oce d ures a n d ti mi n g f or p u blic dis clos ure of t he res ul ts s u m mar y a n d f or 
de vel o p me nt of a ma n uscri pt f or p u blicat i on will be i n acc or da nce wit h G S K P olic y.
A ma n uscri pt will be pr o gresse d f or p u blicat i on i n t he scie nt ific literat ure if t he 
res ults pr o vide i m p orta nt sci e nt ific or me dical k no wl e d ge.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 3 of 1 2 2

1 1 . R E F E R E N C E S
A kra m S, M o ura ni S, O u C N, R o g ner u d C, Sa di q R, G o o d ga me R W. Assess me nt of 
i ntest i nal per mea bility wi t h a t w o-h o ur uri ne c o llecti o n. Di g Dis Sci. 1 9 9 8 
Se p; 4 3( 9): 1 9 4 6 - 5 0.
Alcai de M L, Bis n o A L. P har y n git is a n d e pi gl ottitis. I nfect Dis Cli n N ort h A m 2 0 0 7; 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
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D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
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T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
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R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
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D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
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Pa ge 9 7 of 1 2 2

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D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 9 8 of 1 2 2

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2 0 0 8.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
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5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
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1 2 . A P P E N DI C E S
1 2 . 1. A p pe n di x 1 - A b bre vi ati o ns a n d Tr a de m ar ks
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a d verse e ve nt
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C hil dre n i n Care
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C O M M O N T E R MI N O L O G Y C RI T E RI A F O R 
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hei g ht -f or-a ge Z-sc ores
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i nter nat i onal c o nfere nce o n har m o n isatio n of  tec h nical 
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D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 0 of 1 2 2

L S L V
last s u bject last visit
M F C
master f or m ulat i on c o de
m g
M illi gra m
ml
M illiliter
M M N
m ult i ple micr o n utrient
M N
m ult i ple n utrie nt
NI N
Nati o nal I nst itut e of N utriti o n
oC
de gree ce nt i gra de
oF
de gree Fa hre n heit
PII
pers o nall y i de nt ifia ble i nf or mati on
P P
per pr ot oc ol
P R O
pati e nt re p orte d o utc o me
R D A
Rec o m me n de d Dietar y All o wa nce
S A E
serio us a d verse e ve n t
S C A
Sali va C o llecti on Ai d
S D
sta n dar d de viati on
sI G A
sali var y i m m u n o gl o b uli n A
S A P
statistical a nal ysis pla n
S O S
Sali va Bi o Or al S wa b
S P
St u d y  P h ysicia n
D F
Di a g n osis F or m
S P W R
St u d y  P h ysicia n Wee kl y Re vie w
s TfR
ser u m tra nsferri n rece pt or
U R TI 
u p per res pi rat or y tract i nfecti o n
U NI C E F
U nite d Nat i ons I nter nat i onal C hil dre n’s E mer ge nc y  
F u n d
W H O
W o rld Heal t h Or ga nisat i on
Y L D
Years l ost d ue t o Di sa bilit y
yrs
years
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 1 of 1 2 2

1 2. 2. A p pe n di x 2 - Pr o d uct N u triti o n al Pr ofile
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 2 of 1 2 2
C CI

1 2. 3. A p pe n di x 3 - P are nt/ L A R re p orte d S y m pt o m C hec klist
Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _ Wee k: Fr o m _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
T o     _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
De ar P are nt/ L A R,
Ple ase re p ort t o st u dy st aff a ny ot her sy m pt o ms n ot lis te d bel o w. 
Ple ase use D D/ M M/ Y Y Y Y f or m at f or e nteri n g d ates.
Ple ase use t he f oll o w i n g g ui deli nes t o gr a de i nte nsity-
1Mil d – easil y t olerate d, ca usi n g mi ni mal disc o mf ort a n d n ot i nterferi n g wit h n or mal e very da y 
acti vities.
2M o derate – s ufficie ntl y disc o mf orti n g t o i nterfere wit h n or mal e ver y da y acti vities.
3Se vere – a n y e ve nt t hat pre ve nts n or mal e ver y da y acti vities.
S y m pt o m
D ate
Yes      N o
N o of l o ose st o ols p asse d 
i n a d a y
3           4 -6          ≥7
Di arr hea/ 
L o ose st o ol
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
S y m pt o m
D ate
Yes      N o
N o of b o uts i n a d a y
1 -2          3 - 5         ≥6
V o mit i ng
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 3 of 1 2 2

Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _  Wee k: Fr o m _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
T o     _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _ 
S y m pt o m
D ate
Yes      N o
Or al b o d y te m per at ure 
re a di n g
9 9. 6 -1 0 1. 4° F   1 0 1. 5 -1 0 3. 2° F     ≥1 0 3. 4° F
Fe ver
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
S y m pt o m
D ate
Yes      N o
I nte nsit y
Mil d
1   M o der ate
2 Se vere 3
Dr y  c o u g h
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
  □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
S y m pt o m
D ate
Yes      N o
I nte nsit y
Mil d
1   M o der ate
2 Se vere 3
Wet c o u g h
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _ 
□        □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 4 of 1 2 2

C o m plete d b y:
N a m e:
Si g nat ure & Date:
Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _  Wee k: Fr o m _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
T o     _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
S y m pt o m
D ate
Yes      N o
Mil d
1   M o der ate
2 Se vere 3
S ore t hr oat
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
S y m pt o m
D ate
Yes      N o
Mil d
1   M o der ate
2 Se vere 3
R u n n y N ose
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _ 
□        □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
S y m pt o m
D ate
Yes      N o
Mil d
1   M o der ate
2 Se vere 3
S neezi n g
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
_ _/ _ _ _ / _ _ _ _
□         □
□  
   □           □
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 5 of 1 2 2

C o m plete d b y:
N a m e:
Si g nat ure & Date:
1 2 . 4. A p pe n di x 4 - Pr o d uct C o m pli a nce Re p ort 
( F or h o me use o nl y) 
Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _ F or m N u m ber _ _ _ _ _ _ _ _ _ _ _ _  
De ar P are nt/ L A R, 
Ple ase ret ai n t he e m pty pr o d uct s ac het a n d 
Ple ase e nter bel o w  i n c ase y o ur c hil d di d n ot t ake at all/t o ok p arti ally a ny of t he 
st u dy dri nk d oses t h at y o u g ave at h o me. 
D ate
   D ose
    V ol u me of left o ver 
( D D/ M M M/ Y Y Y Y)
        ( Ple ase tick)
dri n k ( m L)
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
1 st
2 n d
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 6 of 1 2 2

1 2 . 5. A p pe n di x 5 - Di a g n osis F or m ( D F)
Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _ Wee k: Fr o m _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
T o     _ _ _ _/ _ _ _ _ _ _/ _ _ _ _ _ _ _ _  
1.
Was a pare nt/ L A R s y m pt o m c hec klist recei ve d f or t his wee k ? Yes/ N o
2.
Di d t he s u bject i nf or m t he st u d y p h ysic ia n directl y of a n y S y m pt o ms? Yes/ N o
3.
If a n y s y m pt o ms were c o nfir me d, was a dia g n osis f or GI a n d res pirat or y ill nesses
pr o vi de d b y t he st u d y  p h ysicia n? Yes/ N o/ N ot a p plica ble
N ote:
a)
If a p plica ble, fill o ut t he f oll owi n g dia g n osis c hart 
b)
N o. of ill da y s will be calc ulate d pr o gra m maticall y f or GI a n d res pirat or y 
ill nesses re p orte d i n t he st u d y.
c)
Sc h o ol  a bse nteeis m i n t he D F will be mar ke d f or a bse nteeis m d ue t o GI a n d 
res pir at or y ill nesses o nl y .
d)
N u m ber of e pis o des of ill ness f or a partic ular wee k will be deter mi ne d 
pr o gra m mat icall y.
e)
Pare nts/ L A R will als o be as ke d t o re p ort t o t he st u d y  p h ysicia n/st u d y staff a n y 
ot her s y m pt o ms o bser ve d i n parti ci pa nts b ut are n ot liste d pare nt/ L A R 
s y m pt o m c hec klist a n d will be e ntere d i n t he A E f or ms. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 7 of 1 2 2

                       Di a g n osis
Occ urre nces i n
t his wee k
GI Ill nesses
( Yes          N o          )
Res pir at or y Ill nesses
( Yes              N o           )
Di arr he a
V o miti n g
First Occ urre nce
A E Re p ort N u m ber (fr o m pa per A E f or m) 
Start Date
E n d Date
Se v erit y  
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Sc h o ol a bse nteeis m ( N o. of da ys i n t his wee k)
A E N u m ber (fr o m e C R F)
Sec o n d Occ urre nce
A E Re p ort N u m ber (fr o m pa per A E f or m) 
Start Date
E n d Date
Se verit y
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Sc h o ol a bse nteeis m 1 ( N o. of da ys i n t his wee k)
A E N u m ber (fr o m e C R F)
T hir d Occ urre nce
A E Re p ort N u m ber (fr o m pa per A E f or m) 
Start Date
E n d Date
Se verit y
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Sc h o ol a bse nteeis m ( N o. of da ys i n t his wee k)
A E N u m ber (fr o m e C R F)
F o urt h Occ urre nce
A E Re p ort N u m ber (fr o m pa per A E f or m) 
Start Date
E n d Date
Se verit y
Mil d
M o derate
Se vere
Mil d
M o derate
Se vere
Mil d
M o der ate
Se vere
Sc h o ol a bse nteeis m ( N o. of da ys i n t his wee k)
A E N u m ber (fr o m e C R F)
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 8 of 1 2 2

C o m plete d b y:
N a m e:
Si g nat ure & Date:
Se verit y of  GI a n d res pirat or y ill nesses will be ca pt ure d b y  st u d y p h ysicia n as per 
se verity gra di n g ca pt ure d bel o w [ C T C A E 2 0 1 0]:
Ill ness
Mil d *
M o der ate * *
Se vere * * *
GI ill nesses
Diarr hea 
□ I ncrease of < 4 
st o ols per da y o ver 
baseli ne
□ I ncrease of 4 -6 
st o ols per da y o ver 
baseli ne
□ I ncrease of ≥7 st o ols per 
da y  o ver baseli ne; 
i nc o nti ne nce; 
h os pital isati o n i n dicate d; 
life-t hreate ni n g 
c o nse q ue nces; ur ge nt 
i nter ve nti on nee de d
V o miti n g
□ 1 -2 e pis o des 
(se parate d b y 5 
mi n utes) i n 2 4 hrs
□ 3 -5 e pis o des 
(se parate d b y 5 
mi n utes) i n 2 4 hrs
□ ≥6 e pis o des (se parate d 
b y 5 mi n utes) i n 2 4 hrs; 
t u be fee di n g, t otal 
pare nteral n utriti o n or 
h os pital isati o n in dicate d; 
life-t hreate ni n g 
c o nse q ue nces; ur ge nt 
i nter ve nti on i n dicate d
R es pir at or y ill nesses
A RI
□ As y m pt o matic or 
mil d s y m pt o ms; 
cli nical or dia g n ostic 
o bser vati o ns o nl y;
i nter ve nti on n ot 
i n dicate d
□ Mi ni mal, l ocal or 
n o ni n vasi ve 
i nter ve nti on i n dicate d;
li miti n g a ge-
a p pr o priate 
i nstr u me ntal Acti vities 
of Dail y  Li vi n g 
( A D L). I nstr u me ntal 
A D L refer t o sc h o ol 
atte n da nce, pla yi n g, 
st u d yi n g, partici pati n g 
i n sc h o ol acti vities.
□ Se vere or me dicall y 
si g nifica nt, b ut n ot 
i m me diatel y life-
t hreate ni n g; 
h os pital isati o n or 
pr ol o n gati o n of 
h os pital isati o n i n dicate d; 
disa bli n g; li miti n g self -
care A D L.
Life -t hreate ni n g 
c o nse q ue nces; ur ge nt 
i n dicati o n i n dicate d.
* Mil d ( Gra de 1 as per C T C A E 2 0 1 0) - As y m pt o matic or mil d s y m pt o ms; cli nical or dia g n ostic 
o bser vati o ns o nl y ; i nter ve nti on n ot i n dicate d.
* * M o der ate ( Gra de 2 as per C T C A E 2 0 1 0 ) - Mi ni mal, l ocal or n o n -i n vasi ve i nter ve nti o n i n dicate d; 
li miti n g a ge-a p pr o priate i nstr u me ntal Acti vities of Dail y Li vi n g ( A D L). I nstr u me ntal A D L refer t o 
sc h o ol atte n da nce, pla yi n g, st ud yi n g, partici pati n g i n sc h o ol acti vities.
* * * Se vere ( Gra de 3 & 4 as per C T C A E 2 0 1 0) - ( Gra de 3) Se vere or me dicall y si g nifica nt, b ut n ot 
i m me diatel y life-t hreate ni n g; h os pitalisati o n or pr ol o n gati o n of h os pital isati o n i n dicate d; disa bli n g; 
li miti n g self-care A D L. ( Self-care A D L refers t o bat hi n g, dressi n g a n d u n dressi n g, fee di n g self, usi n g 
t he t oilet, ta ki n g me dicati o ns, a n d n ot be dri d de n.) ( Gra de 4) Life-t hreate ni n g c o nse q ue nces; ur ge nt 
i n dicati o n i n dicate d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 0 9 of 1 2 2

1 2. 6 . A p pe n di x 6 - 2 4 h o ur D iet ar y R ec all
Sc ree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _ Visit N u m ber _ _ _ _ _ _ _ _ _ _ _ _ 
D ate: _ _ _/ _ _ _ _/ _ _ _ _ _ ( D D/ M M M/ Y Y Y Y)
Is t his a t y pic al d a y ? Yes or N o _ _ _ _ _ _ _ _
T o p are nts/ L A Rs
“I a m g oi n g t o ask y o u a b o ut everyt hi n g t h at ( N A M E O F C HI L D) ate a n d dr a nk yester d ay. By t his I 
me a n, 2 4 h o urs fr o m mi d ni g ht t o mi d ni g ht. I w o ul d like t o k n o w ex actly w h at w as e ate n a n d dr a nk a n d 
h o w  m uc h ( N A M E O F C HI L D) h a d. ”
T o C hil d
“I w ill ask y o u t o tell me a b o ut a ny f o o ds a n d dri nks w hic h y o ur ( M U M, D A D ( m ai n f o o d pr ovi der)) 
d oes n ot k n o w a b o ut or c a n n ot re me m ber. Is t h at ok ay ? [ W ait f or a gree me nt]. ”
F o o d/ be ver a ge 
Ite m
Descri pti o n
( H o me m a de/ B o u g ht)
P orti o n 
Size
Reci pe 1
(1A p plic a ble
o nly if 
h o me m a de )
Br a n d 2
(2A p plic a ble 
o nly if b o u g ht)
M or ni n g
M or ni n g S n ac ks
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 1 0 of 1 2 2

F o o d/ be ver a ge 
Ite m
Descri pti o n
( H o me m a de/ B o u g ht)
P orti o n 
Size
Reci pe 1
(1A p plic a ble
o nly if 
h o me m a de )
Br a n d 2
(2A p plic a ble 
o nly if b o u g ht)
L u nc h
E ve ni n g S n ac ks
Di n ner
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 1 1 of 1 2 2

F o o d/ be ver a ge 
Ite m
Descri pti o n
( H o me m a de/ B o u g ht)
P orti o n 
Size
Reci pe 1
(1A p plic a ble
o nly if 
h o me m a de )
Br a n d 2
(2A p plic a ble 
o nly if b o u g ht)
A n y ot her 
F o o d/ Be ver a ge
C o m plete d b y -
N a m e:
Si g nat ure & Date:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 1 2 of 1 2 2

C o m plete d b y -
N a m e:
Si g nat ure & Date:
1 2. 7 . A p pe n di x 7 - Diet ar y Di versit y Q uesti o n n aire
Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _ Visit N u m ber _ _ _ _ _ _ _ _ _ _ _ _ 
D ate: _ _ _/ _ _ _ _/ _ _ _ _ _ ( D D/ M M M/ Y Y Y Y)
T o be fille d b ase d o n t he i nf or m ati o n rec or de d i n 2 4 hr diet ary rec all. F or a ny f o o d gr o u ps n ot 
me nti o ne d, ask t he res p o n de nt if a f o o d ite m fr o m t his gr o u p w as c o ns u me d.
Q uesti o n
Y E S = 1
n u m ber
F o o d gr o u p
E x a m ples
N O = 0
1
C E R E A L S
c or n/ maize, rice, w heat, s or g h u m, millet or
a n y ot her grai ns or f o o ds ma de fr o m t hese
(e. g. brea d, n o o dles, p orri d ge or ot her
grai n pr o d ucts) + a ny ot her l oc al f o o ds
2
W HI T E R O O T S
w hite p otat oes, w hite ya m, w hite cassa va,
A N D T U B E R S
or ot her f o o ds m a de fr o m r o ots
3
VI T A MI N A RI C H
p u m p ki n, carr ot, s q uas h, or s weet p otat o
V E G E T A B L E S
t hat are ora n ge i nsi de + ot her l oc ally
A N D T U B E R S
av ail a ble vit a mi n A ric h ve get a bles (e. g.
re d s weet pe p per)
4
D A R K G R E E N
dar k gree n leaf y ve geta bl es, i ncl u di n g wil d
L E A F Y
f or ms + l oc ally av ail a ble vit a mi n A ric h
V E G E T A B L E S
le aves s uc h as a m ar a nt h, c ass av a le aves,
k ale, s pi n ac h
5
O T H E R
ot her ve geta bles (e. g. t o mat o, o ni o n,
V E G E T A B L E S
e g g pla nt) + ot her l oc ally av ail a ble
ve get a bles
6
VI T A MI N A RI C H
ri pe ma n g o, ca ntal o u pe, a pric ot (fres h or
F R UI T S
drie d), ri pe pa pa ya, drie d peac h, a n d 1 0 0 %
fr uit j uice ma de fr o m t hese + ot her l oc ally
av ail a ble vit a mi n A ric h fr uits
7
O T H E R F R UI T S
ot her fr uits, i ncl u di n g wil d fr uits a n d
1 0 0 % fr uit j uice ma de fr o m t hese
8
O R G A N M E A T
li ver, ki d ne y, heart or ot her or ga n meats or
bl o o d -base d f o o ds
9
F L E S H M E A T S
beef, p or k, la m b, g oat, ra b bit, ga me,
c hic ke n, d uc k, ot her bir ds, i nsects
1 0
E G G S
e g gs fr o m c hic ke n, d uc k, g ui nea f o wl or
a n y ot her e g g
1 1
FI S H A N D
fres h or drie d fis h or s hellfis h
S E A F O O D
1 2
L E G U M E S, N U T S
drie d bea ns, drie d peas, le ntils, n uts, see ds
A N D S E E D S
or f o o ds ma de fr o m t hese (e .g. h u m m us,
pea n ut b utt er)
1 3
MI L K A N D MI L K
mil k, c heese, y o g urt or ot her mil k
P R O D U C T S
pr o d ucts
1 4
OI L S A N D F A T S
oil, fats or b utter a d de d t o f o o d or use d f or
c o o ki n g
1 5
S W E E T S
s u gar, h o ne y, s weete ne d s o da or s weete ne d
j uice dri n ks, s u gar y f o o ds s uc h as
c h oc olates, ca n dies, c o o kies a n d ca kes
1 6
S PI C E S,
s pices ( blac k pe p per, salt), c o n di me nts
C O N DI M E N T S,
(s o y sa uce, h ot sa uce), c offee, tea, alc o h olic
B E V E R A G E S
be vera ges
T otal
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 1 3 of 1 2 2

Scree ni n g N u m ber _ _ _ _ _ _ _ _ _
1 2. 8 . A p pe n di x 8 - Diet ar y C o u nselli n g Sessi o ns
A. Diet ar y C o u nselli n g Sessi o ns F or P are nts/ L A Rs
T H E M E
A C TI O N P OI N T S
A.
T o pics f or Diet ar y E d uc ati o n
( Detaile d descri pti on are m e ntio ne d i n t he 
res pecti ve NI N Dietar y g ui deli nes)
B.
Diet ar y A d vices 
S E S SI O N 1
Eat vari et y of  fo o ds t o 
e ns ure a bala nce d diet
( based o n NI N Di et ar y 
G ui deli ne N o 1)

W h y d o we nee d n utrit i onall y  a de q uate 
f oo ds?

W hat i s a bala nce d diet?

W hat are f o o d gr o u ps?

W hat are n utrie nt re q uire me nts a n d 
rec o m me n de d dietar y allo wa nces ( R D A)?

C h o ose e ner g y -ric h, b o d y b uil di n g a n d pr otecti ve f o o ds (mil k, 
ve geta bles a n d fr uits) f or t he c hil dre n i n sc h o ol g oi n g a ge gr o u p.

Use a c o m bi nat i on of w h ole grai ns, gra ms a n d gree ns. I ncl u de 
ji g ger y or s u gar a n d c o o ki n g oils t o bri d ge t he cal orie or e ner g y  
ga p.

Prefer fres h, l ocall y  a vaila ble ve geta bles a n d fr uits i n ple nty.

I ncl u de i n t he diets, f o o ds of a ni mal ori gi n s uc h as mil k, e g gs a n d 
meat, partic ularl y f or pre g na nt a n d lactati n g w o me n a n d c hil dre n.

A d ults s h o ul d c h o ose l o w- fat, pr otei n-ric h fo o ds s uc h as lea n meat, 
fis h, p ul ses a n d lo w -fat mil k.

De vel o p h ealt hy eat i n g ha bits a n d e xercise re g ularl y a nd m o ve as 
m uc h as yo u ca n t o a v oi d se de ntar y  lifestyle.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

E ns ure a de q uate a n d a p pr o priate diets 
f or c hil dre n a n d a d olesce nts b ot h i n 
healt h a n d sic k ness 
( base d o n NI N Dietar y G uideli ne N o 
5)

W h y d o c hil dre n r e q uir e mor e f o o d ?

H o w d o i nfect i ons i n c hil dre n lea ds t o 
mal n utrit i on?

H o w s h o ul d a c hil d be fe d d uri n g 
i nfecti ons?

W hat s h o ul d be d o ne d uri n g diarr hea

H o w i m p orta nt is t he pr o ble m o f 
lact ose i nt olera nce?
D uri n g ill ness

Ne ver star ve t he c hil d.

Fee d e ner g y -ric h cereals- p ulse diet wi t h mil k a n d mas he d 
ve geta bles.

Fee d s mall q ua ntit ies at fre q ue nt i nter vals.

Gi ve ple nt y of  fl ui ds d uri n g ill ness.

Use oral  re h y drati on s o l uti on t o pre ve nt a n d c orrect 
de h y drat i on d uri n g di arr hea e pis o des
Eat pl e nt y of  ve geta bles a n d fr uits
( base d o n NI N Diet ar y G uideli ne N o 
6)

W h y s h o ul d we eat ve geta bles/fr uits?

W hat f u ncti o ns d o t hese n utrie nts a n d 
s pecial fact ors i n ve geta bles/fr uits
perf or m  in o ur b o d y?

W hic h ve geta bles a n d fr uits s h o ul d be 
c o ns u me d?

H o w t o pre ve nt c o o ki n g l osses?

H o w d o we get t hese f o o ds?

H o w t o acc o m m o date m ore ser vi n gs of 
ve geta bles a n d fr uits i n a da y?

Eat as m uc h of ot her ve geta bles as p ossi ble dail y.

Eat ve geta bles/ fr uits i n all y o ur meals i n vari o us f or ms 
(c urr y, s o u ps, mi xe d wit h c ur d, a d de d t o p ulse pre paratio ns 
a n d rice).

C o ns u me ra w a n d fres h ve geta bles as sala ds.

Gr o w t he fa mil y's re q uire me nts of ve geta bles i n t he kitc he n 
gar de n if p ossi ble.

Gree n leaf y  ve geta bles, w he n pr o perl y clea ne d a n d c o o ke d 
are safe e ve n f or i nfa nts.

Let differe nt varietie s of ve geta bles a n d fr uits a d d c ol or t o 
y o ur pl ate a n d vitalit y t o y o ur life.

Beta -car ote ne ric h f o o ds li ke dar k gree n, yello w a n d ora n ge
c olore d ve geta bles a n d fr uits ( G L Vs, carr ots, pa pa ya a n d 
ma n g oes) pr otect fr o m vita mi n A deficie nc y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

        
C o m plete d b y -
Na m e:
Si g nat ure & Date:
A v o i d o vereati n g t o pre ve nt 
o ver wei g ht a n d o besit y
( base d o n NI N Dietar y G uideli ne N o 
8)

W hat i s o besity?

W hat i s desira ble b o d y w eig ht or B o d y  
mass I n de x ( B MI)?

Ce ntral  o besit y

W h y s h o ul d we a v o i d o besity?

W hat ca uses o besit y?

H o w t o re d uce b o d y  w eig ht ?

Sl o w a n d stea d y  re d uctio n i n b o d y  wei g ht is a d visa ble.

Se vere fast i n g ma y lea d t o healt h hazar ds.

Ac hie ve e ner g y bala nce a n d a p pr o priate wei g ht f or hei g ht.

E nc o ura ge re g ular p h ysical act i vity.

Eat s mall meals re g ularl y at fre q ue nt i nter vals.

C ut d o w n s u gar, salt, fatt y f oo ds, refi ne d f o o ds, s oft dri n ks 
a n d alc o h o l.

Eat c o m ple x car b o h y drates, l o w gl yce mic f o o ds a n d fi bre 
ric h diets.

I ncrease c o ns u m pti o n of fr uits a n d ve geta bles, le g u mes, 
w h o le grai ns a n d n uts.

Li mit fat i nta ke a n d s hift fr o m sat urate d t o u nsat urate d fats.

A v o i d tra ns-fatt y ric h fo o ds ( va nas pat i, ba ker y pr o d ucts 
a n d s weets).

Use l o w - fat mil k.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _
S E S SI O N 2
E ns ure t he use of safe a n d clea n f o o ds
( base d o n NI N Dietar y G uideli ne N o 
1 1)

W hat m a kes f o o d u nsafe?

H o w d o we select safe f o o d?

W hat are t he best practices of 
st ora ge?

W h y d o f o o d b or ne diseases 
occ ur?

H o w s h o ul d peris ha ble f o o ds be 
ha n dle d?

W hat a b o ut pers o nal h y gie ne?

W hat are t he c o m m o n 
a d ultera nts?

H o w t o mi ni m ise effects of 
pestici de resi d ues?

B u y  fo o d i t e ms fr o m relia ble s o urces after caref ul 
e xa mi nat i on.

Was h ve geta bles a n d fr uits t h or o u g hl y bef ore use.

St ore t he ra w a n d c o o ke d f o o ds pr o perl y  a n d pre ve nt 
micr o bial, r o de nt a n d i nsect i n vasi on.

Refri gerate peris ha ble f o o d ite ms.

Mai ntai n g o o d pers o nal h y gie ne a n d kee p t he c o o ki n g 
a n d f o o d st ora ge areas clea n a n d safe.

Al wa ys use t h or o u g hl y  clea ne d ute nsils f or c o o ki n g/ 
eati n g.
A d o pt ri g ht pre -c o o ki n g pr ocesses a n d 
a p pr o priate c o o ki n g met h o ds 
( base d o n NI N Dietar y G uideli ne N o 
1 2)

W hat are c o m m o n I n dia n f o o d 
beliefs, fa ds a n d ta b o os?

W hat are t he effects of t he pre -
c o o ki n g pr ocesses?

W hat are t he effects of was hi n g 
a n d c utti n g?

W hat are t he effects of c o o ki n g?

Micr o wa ve C o o ki n g

D o n ot was h f o o d grai ns re peate dl y bef ore c o o ki n g.

D o n ot was h ve geta bles after c utti n g.

D o n ot s oa k t he c ut ve geta bles i n water f or l o n g 
p eri o ds.

D o n ot di scar d t he e xcess water left o ver after c o o ki n g. 
Use o nl y s ufficie nt water f or c o o ki n g.

C o o k f o o ds i n vessels c o vere d wit h li ds.

Prefer press ure/stea m c o o ki n g t o dee p fr yi n g/r oasti n g.

E nc o ura ge c o ns u m pt i on of s pr o ute d/fer me nte d f o o ds.

A v o i d use of ba ki n g s o da w hile c o o ki n g p ulses a n d 
ve geta bles.

D o n ot re heat t he left o ver oil re peate dl y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

C o m plete d b y -
Na m e:
Si g nat ure & Date:
Dri n k pl e nt y of  water a n d ta ke 
be vera ges i n m o derati o n 
( base d o n NI N Dietar y 
G ui deli ne N o 1 3)

W h y d o we nee d wate r?

W he n is water c o nsi dere d safe a n d 
w h o les ome ?

H o w i s water re n dere d safe?

H o w n utrit i ous i s mil k?

W hat i s lact ose i nt olera nce?

W hat are s oft dri n ks?

W hat a b o ut tea a n d c offee?

Te n der c oc o n ut water

Alc o h o l

Dri n k e n o u g h of safe a n d w h o les ome water t o meet 
dail y  fl ui d re q uire me nts.

Dri n k b o ile d water, w he n safety of  t he water is i n 
d o u bt.

C o ns u me at least 2 5 0 ml of b o ile d or paste urise d
mil k per da y .

Dri n k nat ural a n d fres h fr uit j uices i nstea d of 
car b o nate d be vera ges.

Prefer tea o ver c offee.

A v o i d alc o h ol. T h ose w h o dri n k s h o ul d li mit its 
i nta ke.
Mi ni mize t he use of pr ocesse d 
f oo ds ri c h i n salt, s u gar a n d fats
(base d o n NI N Dietar y  
G ui deli ne N o 1 4)

W hat are pr ocesse d f o o ds?

D o we nee d pr ocesse d f o o ds?

D o pr ocesse d f o o ds c o ntri b ute t o n utrie nt 
i nta ke?

W hat i s t he differe nce bet wee n i nsta nt f o o ds, 
fast f o o ds, street f o o ds a n d u n healt h y (j u n k) 
f oo ds?

W h y s h o ul d we restrict i nta ke of u n healt h y 
pr ocesse d f o o ds?

W h y s h o ul d we m o derate i nta ke of s u gar ?

Prefer tra dit i onal, h o me ma de f o o ds.

A v o i d re placi n g meals with s nac k f o o ds.

Li mit c o ns u m pt i on of s u gar a n d u n healt h y 
pr ocesse d f o o ds w hic h pr o vi de o nl y  ( e m pt y) 
calori es.

Prefer f ortifie d pr ocesse d f o o ds.

Al wa ys rea d f o o d la bels ( gi ve n o n c o ntai ners) 
re gar di n g c o nte nt of n utri e nts, s helf-life a n d t he 
a d ditives prese nt.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _
B. Diet ar y C o u nselli n g Sessi o ns F o r  C hil dre n
T H E M E
A C TI O N P OI N T S
A.
T o pics f or Diet ar y E d uc ati o n
( Detaile d descri pti on are m e ntio ne d i n t he 
res pecti ve NI N Dietar y g ui deli nes)
B.
Diet ar y A d vices 
S E S SI O N 1
Eat vari et y of  fo o ds t o 
e ns ure a bala nce d diet
( base d o n NI N Diet ar y 
G ui deli ne N o 1)

W h y d o we nee d n utrit i onall y  a de q uate 
f oo ds?

W hat i s a bala nce d diet?

W hat are f o o d gr o u ps?

C h o ose e ner g y -ric h, b o d y b uil di n g a n d pr otecti ve f o o ds ( mil k, 
ve geta bles a n d fr uits).

Use a c o m bi nat i on of w h ole grai ns, gra ms a n d gree ns. 

I ncl u de ji g ger y or s u gar a n d c o o ki n g o ils t o bri d ge t he cal orie or 
e ner g y ga p.

Prefer fres h, l ocall y  a vaila ble ve geta bles a n d fr uits i n ple nty.

I ncl u de i n t he diets, f o o ds of a ni mal ori gi n s uc h as mil k, e g gs a n d 
meat, partic ularl y f or pre g na n t a n d lactati n g w o me n a n d c hil dre n.

A d ults s h o ul d c h o ose l o w- fat, pr otei n-ric h fo o ds s uc h as lea n meat, 
fis h, p ul ses a n d lo w -fat mil k.

De vel o p healt h y eat i n g ha bits a n d e xercise re g ularl y a nd m o ve as 
m uc h as yo u ca n t o a v oi d se de ntar y  lifestyle.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

        
C o m plete d b y -
Na m e:
Si g nat ure & Date:
Eat pl e nt y of  
ve geta bles a n d fr uits
( base d o n NI N Diet ar y 
G ui deli ne N o 6 )

W h y s h o ul d we eat ve geta bles/fr uits?

W hat f u ncti o ns d o t hese n utrie nts a n d 
s pecial fact ors i n ve geta bles/fr uits p erf or m  
i n o ur b o d y?

W hic h ve geta bles a n d fr uits s h o ul d be 
c o ns u me d?

H o w t o pr e ve nt c o o ki n g l osses?

H o w d o we get t hese f o o ds?

H o w t o acc o m m o date m ore ser vi n gs of 
ve geta bles a n d fr uits i n a da y?

Eat as m uc h of ot her ve geta bles as p ossi ble dail y.

Eat ve geta bles/ fr uits i n all y o ur meals i n vari o us f or ms (c urr y ,
s o u ps, mi xe d wit h c ur d, a d de d t o p ulse pre parati o ns a n d rice).

C o ns u me ra w a n d fres h ve geta bles as sala ds.

Gr o w t he fa mil y's re q uire me nts of ve geta bles i n t he kitc he n gar de n if 
p ossi ble.

Gree n leaf y  ve geta bles, w he n pr o perl y clea ne d a n d c o o ke d are safe 
e ve n f or i nfa nts.

Let dif fere nt varieties of ve geta bles a n d fr uits a d d c ol or t o yo ur plate 
a n d vitalit y t o y o ur life.

Beta -car ote ne ric h f o o ds li ke dar k gree n, yello w a n d ora n ge c olore d 
ve geta bles a n d fr uits ( G L Vs, carr ots, pa pa ya a n d ma n g oes) pr otect 
fr om vit a mi n A deficie nc y.
E ns ure t he use of safe 
a n d clea n f o o ds
( base d o n NI N Dietar y 
G ui deli ne N o 1 1)

W hat m a kes f o o d u nsafe?

H o w d o we select safe f o o d?

W hat are t he best practices of st ora ge?

W h y d o f o o d b or ne diseases occ ur?

H o w s h o ul d peris ha ble f o o ds be ha n dle d?

W hat a b o ut p ers o nal h y gie ne?

W hat are t he c o m m o n a d ultera nts?

H o w t o mi ni m ise effects of pest ici de 
resid u es ?

B u y  fo o d i t e ms fr o m relia ble s o urces after caref ul e xa mi nati on.

Was h ve geta bles a n d fr uits t h or o u g hl y bef ore use.

St ore t he ra w a n d c o o ke d f o o ds pr o perl y  a n d pre ve nt micr o bial,
r o de nt a n d i nsect i n vasi o n.

Refri gerate peris ha ble f o o d ite ms.

Mai ntai n g o o d pers o nal h y gie ne a n d kee p t he c o o ki n g a n d f o o d
st ora ge areas clea n a n d safe.

Al wa ys use t h or o u g hl y  clea ne d ute nsils f or c o o ki n g/ eati n g.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

Scree ni n g N u m ber _ _ _ _ _ _ _ _ _ _ _ _
C o m plete d b y -
N a m e:
Si g nat ure & Date:
S E S SI O N 2
Dri n k pl e nt y of  water a n d ta ke 
be vera ges i n m o derati o n 
( base d o n NI N Dietar y 
G ui deli ne N o 1 3)

W h y d o we nee d water?

W he n is water c o nsi dere d safe a n d 
w h o les ome ?

H o w i s water re n dere d safe?

H o w n utrit i ous i s mil k?

W hat i s lact ose i nt olera nce?

W hat are s oft dri n ks ?

W hat a b o ut tea a n d c offee?

Te n der c oc o n ut water

Alc o h o l

Dri n k e n o u g h of safe a n d w h o les ome water t o 
meet dail y  fl ui d re q uire me nts.

Dri n k b o ile d water, w he n safety of  t he water is i n 
d o u bt.

C o ns u me at least 2 5 0 ml of b o ile d or paste urise d
mil k per da y .

Dr i n k nat ural a n d fres h fr uit j uices i nstea d of 
car b o nate d be vera ges.

Prefer tea o ver c offee.

A v o i d alc o h ol. T h ose w h o drin k s h o ul d li mi t its 
i nta ke.
Mi ni mise t he use of pr ocesse d 
f oo ds ri c h i n salt, s u gar a n d fats
(base d o n NI N Dietar y  
G ui deli ne N o 1 4)

W ha t are pr ocesse d f o o ds?

D o we nee d pr ocesse d f o o ds?

D o pr ocesse d f o o ds c o ntri b ute t o n utrie nt 
i nta ke?

W hat i s t he differe nce bet wee n i nsta nt 
f oo ds, fast f o o ds, street f o o ds a n d
u n healt h y (j u n k) f o o ds ?

W h y s h o ul d we restrict i nta ke of u n healt h y 
pr ocesse d f o o ds?

W h y s h o ul d we m o derate i nta ke of s u gar ?

Prefer tra dit i onal, h o me ma de f o o ds.

A v o i d re placi n g meals with s nac k f o o ds.

Li mit c o ns u m pt i on of s u gar a n d u n healt h y 
pr ocesse d f o o ds w hic h pr o vi de o nl y  ( e m pt y) 
calori es.

Prefer f ortifie d pr ocesse d f o o ds.

Al wa ys r ea d f o o d la bels ( gi ve n o n c o ntai ners) 
re gar di n g c o nte nt of n utri e nts, s helf-life a n d t he 
a d ditives prese nt.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e

 
 
SI G N A T U R E P A G E 
 
  
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
 
J ustific ati o n  
 
 
1 0- O ct- 2 0 1 7 0 5: 3 0: 5 0
 
A p pr o v e d
1 0- O ct- 2 0 1 7 0 6: 1 6: 3 8
A p pr o v e d
0 8- O ct- 2 0 1 7 2 1: 1 7: 4 6
Cli ni c al O p er ati o n s A p pr o v al
Bi o st ati sti c s A p pr o v al
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
0 6- O ct- 2 0 1 7 0 8: 5 2: 0 8
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0- O ct- 2 0 1 7 0 6: 1 6: 4 9
 
el d o _ cli ni c al _ d o c
5. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
Cli ni c al St u d y Pr ot o c ol 2 0 4 4 7 7
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d a a 9 5 e
Pa ge 1 2 2 of 1 2 2
P P D
P P D
P P D
P P D