An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand

Study Overview
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Brief Summary
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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.

Official Title
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An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand

Conditions
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Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: fortified extruded rice


Participation Criteria
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Eligibility Criteria
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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%).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fortified extruded rice<br>fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice | Dietary Supplement: fortified extruded rice<br>* fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Zn |  | September 2009-March 2010 | 
| Hemoglobin |  | September 2009-2010 | 
| serum retinol |  | September 2009-March 2010 | 
| serum ferritin |  | September 2009-March 2010 | 
| ZPP |  | September 2009- March 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry measures |  | September 2009-March 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fe deficiency, Zn deficiency, vitamin A deficiency