An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin A Deficiency Iron Deficiency Zinc Deficiency |
Dietary Supplement: fortified extruded rice |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand |
- serum Zn [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
- Hemoglobin [ Time Frame: September 2009-2010 ] [ Designated as safety issue: No ]
- serum retinol [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
- serum ferritin [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
- ZPP [ Time Frame: September 2009- March 2010 ] [ Designated as safety issue: No ]
- Anthropometry measures [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
| Enrollment: | 203 |
| Study Start Date: | September 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
|
Dietary Supplement: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
|
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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%).
Contacts and Locations| Switzerland | |
| Swiss Federal Institute of Technology Zurich | |
| Zurich, Switzerland, 8092 | |
| Thailand | |
| Institute of Nutrition Mahidol University | |
| Phuttamonthon, Nakhon Pathom, Thailand, 73170 | |
More Information
No publications provided by Swiss Federal Institute of Technology
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ETH Zurich, Prof, Swiss Federal Institute of Technology |
| ClinicalTrials.gov Identifier: | NCT01061307 History of Changes |
| Other Study ID Numbers: | ETH2010/1 |
| Study First Received: | February 2, 2010 |
| Last Updated: | April 4, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Swiss Federal Institute of Technology:
|
Fe deficiency, Zn deficiency, vitamin A deficiency |
Additional relevant MeSH terms:
|
Vitamin A Deficiency Night Blindness Anemia, Iron-Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
Vitamin A Vitamins Retinol palmitate Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013