Vitamin A Equivalence of Plant Carotenoids in Children
Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN
2 other identifiers
interventional
72
1 country
1
Brief Summary
Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Shorter than P25 for phase_2
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
First Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 18, 2009
February 1, 2009
6 months
May 16, 2008
February 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
conversion efficiency of b-C to retinol
up to 21 days
Study Arms (1)
1
OTHERdietary carotenoids
Interventions
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
Eligibility Criteria
You may qualify if:
- healthy children
You may not qualify if:
- food allergy
- parasitic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
Study Sites (1)
USDA Human Nutrition Research Center on Aging, Tufts Uni.
Boston, Massachusetts, 02111, United States
Related Publications (1)
Tang G, Hu Y, Yin SA, Wang Y, Dallal GE, Grusak MA, Russell RM. beta-Carotene in Golden Rice is as good as beta-carotene in oil at providing vitamin A to children. Am J Clin Nutr. 2012 Sep;96(3):658-64. doi: 10.3945/ajcn.111.030775. Epub 2012 Aug 1.
PMID: 22854406DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guangwen Tang, Ph. D
Tufts University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 18, 2009
Record last verified: 2009-02