Efficacy of Vitamin A in Fortified Extruded Rice in School Children
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Early Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Triple fortified extruded tice (Fe, Zn and vitamin A)
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin A Deficiency focused on measuring vitamin A deficiency
Eligibility Criteria
Inclusion Criteria:
- Children, aged 8-12 years, both sexes, attending the local primary schools
- No known or reported history of significant chronic illness
- Free of acute illness and febrile and gastrointestinal problems
Exclusion Criteria:
- Children with severe vitamin A deficiency with a clinical sign of Bioit's spot or ocular signs of xerophthalmia will be excluded
- Children who have serum retinol < 0.7 umol/L
Sites / Locations
- Tessaban 3 School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
triple fortified extruded rice
regular meal
Arm Description
regular vitamin A meal
Outcomes
Primary Outcome Measures
Vitamin A in the entire body
A quantitative estimate of the size of exchangeable body pool of vitamin A. The exchangeable body pool of vitamin A refer to the vitamin A in body that is in dynamic state.
Secondary Outcome Measures
Serum retinol
Full Information
NCT ID
NCT01199445
First Posted
August 20, 2010
Last Updated
January 5, 2016
Sponsor
Swiss Federal Institute of Technology
Collaborators
Mahidol University, University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01199445
Brief Title
Efficacy of Vitamin A in Fortified Extruded Rice in School Children
Official Title
Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Mahidol University, University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.
Detailed Description
Iron, zinc and vitamin A deficiencies are particularly common among children and young women in developing countries of South and Southeast Asia. Rice is a common staple for a large part of these sub-regions of Asia. In spite of a wide range of rice varieties eaten, rice is eaten by all age groups and is one of the first few foods used as complementary food for infants.
Fe fortification of rice using a method of heat extrusion and micronized ferric pyrophosphate (FePP) as iron fortificant has shown to be efficacious in increasing iron stores and reducing the prevalence of iron deficiency in Indian school children. Subsequent extrusion trials have shown promising results with respect to color and vitamin A (VA) stability when rice grains were triple fortified with Fe, Zn and vitamin A.
Preliminary data in the region of Satun, South Thailand, have shown 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. Since rice is the main staple food in this area, rice triple fortified with Fe, VA and Zn is a promising strategy to combat micronutrient deficiencies in children.
The aim of this study is to demonstrate whether triple fortified rice has an impact on vitamin A status of children. The study will be conducted in school children (8 to 12 years old). The children will be randomized to either receive a daily lunch rice meal prepared from fortified rice (the triple fortified rice grains will be mixed into natural rice at a ratio of 1:50) or from non-fortified rice for 60 days. As serum retinol concentration, the most widely used indicator for the assessment of vitamin A status, is not a very reliable indicator due to homeostatic control and the influence of infection, we will in addition use the tracer methodology using dilution of stable isotopes with which total body vitamin A pool size will be estimated prior to the intervention and after 60 days of the intervention..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
vitamin A deficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
triple fortified extruded rice
Arm Type
Experimental
Arm Title
regular meal
Arm Type
Other
Arm Description
regular vitamin A meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Triple fortified extruded tice (Fe, Zn and vitamin A)
Intervention Description
Triple fortified extruded rice (Fe, Zn and vitamin A)will be mix at ratio of 1:50 with normal rice then give to children at school lunch meal for 60 days.
Primary Outcome Measure Information:
Title
Vitamin A in the entire body
Description
A quantitative estimate of the size of exchangeable body pool of vitamin A. The exchangeable body pool of vitamin A refer to the vitamin A in body that is in dynamic state.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Serum retinol
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children, aged 8-12 years, both sexes, attending the local primary schools
No known or reported history of significant chronic illness
Free of acute illness and febrile and gastrointestinal problems
Exclusion Criteria:
Children with severe vitamin A deficiency with a clinical sign of Bioit's spot or ocular signs of xerophthalmia will be excluded
Children who have serum retinol < 0.7 umol/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F Hurrell, Ph.D
Organizational Affiliation
Swiss Federal Institute of Technology (ETH,Zurich)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tessaban 3 School
City
Muang
State/Province
Satun
ZIP/Postal Code
91000
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
24500930
Citation
Pinkaew S, Wegmuller R, Wasantwisut E, Winichagoon P, Hurrell RF, Tanumihardjo SA. Triple-fortified rice containing vitamin A reduced marginal vitamin A deficiency and increased vitamin A liver stores in school-aged Thai children. J Nutr. 2014 Apr;144(4):519-24. doi: 10.3945/jn.113.182998. Epub 2014 Feb 5.
Results Reference
derived
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Efficacy of Vitamin A in Fortified Extruded Rice in School Children
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