Retinol Equivalence of Plant Carotenoids in Children
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin A Deficiency
Phase: N/A
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.
The experiments will be conducted in children (ages 6-8) 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, decadeuterium labeled spinach and Golden Rice,
synthetic ß-C-d10 and a vitamin A isotope reference, decadeuterated 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.
Clinical Details
Study design: Other
Detailed description:
Seventy-two children each will take two meals, lunch and supper, containing equal amounts of
ß-C in labeled spinach (along with white rice), or Golden Rice (along with light colored
vegetables), or ß-C oil capsules (along with white rice and light colored vegetables), every
day for 7 days. Before the two meals, the volunteers will take a breakfast with a RAc-d10
dose as a reference for 7 days. The enrichment of labeled ß-C and labeled retinol in human
circulation will be determined using advanced liquid chromatography / mass spectrometry and
gas chromatography / mass spectrometry. Through the applications of these novel technologies,
we will be able to determine the relative biological activities of endogenous carotenoids;
that is, the vitamin A value of spinach, Golden Rice, and ß-C in oil capsules for children
with/without vitamin A malnutrition.
Eligibility
Minimum age: 8 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
7-10 years old
Exclusion Criteria:
Parasitic infection
Locations and Contacts
The Zhejiang Academy of Medical Sciences, Hang Zhou, Zhejiang Proviance 310013, China
Additional Information
Starting date: September 2004
Ending date: November 2005
Last updated: November 15, 2007
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