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

Information source: Swiss Federal Institute of Technology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin A Deficiency; Iron Deficiency; Zinc Deficiency

Intervention: fortified extruded rice (Dietary Supplement)

Phase: Phase 0

Status: Completed

Sponsored by: Swiss Federal Institute of Technology

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

serum Zn

Hemoglobin

serum retinol

serum ferritin

ZPP

Secondary outcome: Anthropometry measures

Eligibility

Minimum age: 7 Years. Maximum age: 12 Years. Gender(s): Both.

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%).

Locations and Contacts

Swiss Federal Institute of Technology Zurich, Zurich 8092, Switzerland

Institute of Nutrition Mahidol University, Phuttamonthon, Nakhon Pathom 73170, Thailand

Additional Information

Starting date: September 2009
Last updated: April 4, 2012

Page last updated: August 20, 2015

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