Efficacy of Vitamin A in Fortified Extruded Rice in School Children
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2010
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJanuary 6, 2016
June 1, 2012
3 months
August 20, 2010
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (1)
Serum retinol
2 months
Study Arms (2)
triple fortified extruded rice
EXPERIMENTALregular meal
OTHERregular vitamin A meal
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- Mahidol Universitycollaborator
- University of Wisconsin, Madisoncollaborator
Study Sites (1)
Tessaban 3 School
Muang, Changwat Satun, 91000, Thailand
Related Publications (1)
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.
PMID: 24500930DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard F Hurrell, Ph.D
Swiss Federal Institute of Technology (ETH,Zurich)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2010
First Posted
September 13, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
March 1, 2011
Last Updated
January 6, 2016
Record last verified: 2012-06