Clinical trial NCT01061307: An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
Official title: An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin A Deficiency
Iron Deficiency
Zinc Deficiency
Keywords: Fe deficiency, Zn deficiency, vitamin A deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2010-02-03
Enrollment: 203
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.

Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.

In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.


Eligibility criteria: Inclusion Criteria:

* Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).
* Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc \< 65, 66 and 70 µg/dL in children \< 10y, male ≥ 10y and female ≥ 10y)

Exclusion Criteria:

* Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.
* Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.
* Low school attendance (\<80%).

Primary outcomes:
measure: serum Zn
timeFrame: September 2009-March 2010
measure: Hemoglobin
timeFrame: September 2009-2010
measure: serum retinol
timeFrame: September 2009-March 2010
measure: serum ferritin
timeFrame: September 2009-March 2010
measure: ZPP
timeFrame: September 2009- March 2010
Secondary outcomes:
measure: Anthropometry measures
timeFrame: September 2009-March 2010
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Swiss Federal Institute of Technology Zurich
city: Phuttamonthon
country: Thailand
facility: Institute of Nutrition Mahidol University
state: Nakhon Pathom
Study officials:
References:
citation: Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.
citation: Pinkaew S, Winichagoon P, Hurrell RF, Wegmuller R. Extruded rice grains fortified with zinc, iron, and vitamin A increase zinc status of Thai school children when incorporated into a school lunch program. J Nutr. 2013 Mar;143(3):362-8. doi: 10.3945/jn.112.166058. Epub 2013 Jan 9.