- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082420
Retinol Equivalence of Plant Carotenoids in Children
To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.
The experiments will be conducted in children (ages 7-9) with/without adequate vitamin A nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast population in the world, it is essential to determine the efficiency of provitamin A carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm, Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice, synthetic ß-C-d10 and a vitamin A isotope reference, deca-deuterated retinyl acetate (RAc-d10), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo.
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.
This study will be of importance in planning vitamin A deficiency prevention strategies and also will provide useful information regarding the potential efficacy of a bioengineered crop to provide vitamin A nutrition.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 7-9 years old
Exclusion Criteria:
- Parasitic infection
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
Collaborators and Investigators
Publications and helpful links
General Publications
- Li L, Wang Y, Wu J, Zhu R. [Bioefficacy of plant carotenoid to vitamin A in school age children]. Wei Sheng Yan Jiu. 2007 Sep;36(5):547-51. Chinese.
- Lei Li, Yin Wang, Shi-an Yin, Michael A Grusak, Robert M Russell, Guangwen Tang. Bioconversion of spinach β-carotene in Chinese children with noemal or marginal vitamin A status. FASEB J. 2006 20:A1319
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RETEQ (completed)
- DK60021
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