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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01061307
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : January 6, 2016
Mahidol University
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Iron Deficiency Zinc Deficiency Dietary Supplement: fortified extruded rice Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin A

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Anthropometry measures [ Time Frame: September 2009-March 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01061307

Swiss Federal Institute of Technology Zurich
Zurich, Switzerland, 8092
Institute of Nutrition Mahidol University
Phuttamonthon, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Swiss Federal Institute of Technology Identifier: NCT01061307     History of Changes
Other Study ID Numbers: ETH2010/1
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: April 2012

Keywords provided by Swiss Federal Institute of Technology:
Fe deficiency, Zn deficiency, vitamin A deficiency

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Vitamin A Deficiency
Night Blindness
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents