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NCT Number: NCT01061307

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

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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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Swiss Federal Institute of Technology Zurich, Zurich, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

fortified extruded rice

Dietary Supplement

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

Primary outcomes

  1. serum Zn

    Time frame: September 2009-March 2010

  2. Hemoglobin

    Time frame: September 2009-2010

  3. serum retinol

    Time frame: September 2009-March 2010

  4. serum ferritin

    Time frame: September 2009-March 2010

  5. ZPP

    Time frame: September 2009- March 2010

Secondary outcomes

  1. Anthropometry measures

    Time frame: September 2009-March 2010

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mahidol University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2010
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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