Clinical trial NCT00741143: Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
Official title: Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Iron Deficiency Anemia
Cognition
Keywords: Food Fortification
Iron deficiency
NaFeEdta
Iron deficiency anemia
Cognition
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: Akzo Nobel
name: Ministry of Science and Technology, India
First posted: 2008-08-26
Enrollment: 194
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving cognition, hemoglobin, iron status and total body iron among school children in urban Bangalore.

Detailed description: Background: Iron (Fe) deficiency is a major cause of anemia in children. Fortification of wheat flour with NaFeEDTA, a highly bioavailable iron fortificant that protects Fe from the phytic acid present in wheat flour, could be a practical approach to addressing this problem.

Aims: To evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving mental performance and reducing iron deficiency and improving body iron stores in urban, school going Indian children.

Methods: A randomized, double-blind, 7 month, school-based feeding trial was carried out in Bangalore, India. Iron-depleted (serum ferritin, SF \<20 µg/L), and/or iron deficient (serum transferrin receptor, TfR \>7.6 mg/L), 6 -13 year old children (N=194) were randomly assigned to either receive a whole wheat flour based lunch meal fortified with 6 mg Fe as NaFeEDTA or an identical unfortified control meal. The meals were administered under supervision and left overs were weighed. Hemoglobin (Hb) and iron status were measured at baseline, 3.5 months, and 7 months. At baseline and at 7 months, the study children were also subjected to a battery of cognitive tests to assess attention/concentration, motor development, visuospatial and verbal abilities. Sensory evaluation using triangle tests were carried out using meals prepared from the fortified and unfortified whole wheat flour.

Eligibility criteria: Inclusion Criteria:

* Children with depleted iron stores (serum ferritin \< 20 µg/L or iron deficiency serum transferrin receptor \>7.6 mg/L)

Exclusion Criteria:

* Hb \< 8g/dl, any metabolic illness, use of medication, on iron supplementation

Primary outcomes:
measure: change in cognitive abilities
timeFrame: 7 months
Secondary outcomes:
measure: changes in iron status indicators
timeFrame: 7 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St Johns Research Institute
state: Karnataka
Study officials:
affiliation: St Johns Research Institute, Sarjapur Road, Bangalore
name: Sumithra Muthayya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muthayya S, Thankachan P, Hirve S, Amalrajan V, Thomas T, Lubree H, Agarwal D, Srinivasan K, Hurrell RF, Yajnik CS, Kurpad AV. Iron fortification of whole wheat flour reduces iron deficiency and iron deficiency anemia and increases body iron stores in Indian school-aged children. J Nutr. 2012 Nov;142(11):1997-2003. doi: 10.3945/jn.111.155135. Epub 2012 Sep 26.