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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00082420 |
Purpose
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.
| Condition |
|---|
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Vitamin A Deficiency |
| Study Type: | Observational |
| Estimated Enrollment: | 72 |
| Study Start Date: | September 2004 |
| Study Completion Date: | November 2005 |
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| Ages Eligible for Study: | 8 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | RETEQ, DK60021 |
| Study First Received: | May 6, 2004 |
| Last Updated: | July 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00082420 |
| Health Authority: | United States: Federal Government |
|
Vitamin A malnutrition low vitamin A status |
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Vitamin A Deficiency Night Blindness Vision Disorders Keratomalacia Avitaminosis Eye Diseases Blindness |
Malnutrition Retinol palmitate Vitamin A Nutrition Disorders Carotenoids Deficiency Diseases |
