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

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ClinicalTrials.gov Identifier: NCT01061307
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

February 2, 2010
February 3, 2010
January 6, 2016
September 2009
March 2010   (Final data collection date for primary outcome measure)
  • serum Zn [ Time Frame: September 2009-March 2010 ]
  • Hemoglobin [ Time Frame: September 2009-2010 ]
  • serum retinol [ Time Frame: September 2009-March 2010 ]
  • serum ferritin [ Time Frame: September 2009-March 2010 ]
  • ZPP [ Time Frame: September 2009- March 2010 ]
Same as current
Complete list of historical versions of study NCT01061307 on ClinicalTrials.gov Archive Site
Anthropometry measures [ Time Frame: September 2009-March 2010 ]
Same as current
Not Provided
Not Provided
 
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
An Efficacy Trial of Fe, Zn 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.

Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Vitamin A Deficiency
  • Iron Deficiency
  • Zinc Deficiency
Dietary Supplement: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
Experimental: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
Intervention: Dietary Supplement: fortified extruded rice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
Same as current
June 2010
March 2010   (Final data collection date for primary outcome measure)

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%).
Sexes Eligible for Study: All
7 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland,   Thailand
 
 
NCT01061307
ETH2010/1
No
Not Provided
Not Provided
Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Mahidol University
Not Provided
Swiss Federal Institute of Technology
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP