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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

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.

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Detailed Description

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Conditions

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Vitamin A Deficiency Iron Deficiency Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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fortified extruded rice

fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

Group Type EXPERIMENTAL

fortified extruded rice

Intervention Type DIETARY_SUPPLEMENT

fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

Interventions

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fortified extruded rice

fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

* 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%).

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes