Vitamin A Equivalence of Plant Carotenoids in Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin A Deficiency |
Dietary Supplement: dietary carotenoids Dietary Supplement: spinach, rice, and synthetic beta-carotene |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN |
- conversion efficiency of b-C to retinol [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
dietary carotenoids
|
Dietary Supplement: dietary carotenoids
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
Dietary Supplement: spinach, rice, and synthetic beta-carotene
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
Other Name: dietary carotenoids
|
Detailed Description:
This project is to determine the vitamin A value (equivalence) of dietary provitamin A carotenes from spinach, Golden Rice, and pure ß-carotene (ß-C) in oil. These experiments will be conducted in children (ages 6-8) with/without adequate (marginal deficiency) 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, C13 labeled retinyl acetate (13C10-RAc), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo.
Seventy-two children each will take two meals, breakfast containing 13C10-RAc dose (0.5mg in 0.2g oil capsule) and lunch containing spinach containing 1 mg ß-C (along with white rice), or Golden Rice containing 0.5mg ß-C (along with light colored vegetables), or ß-C oil capsules containing 0.5 mg ß-C in 0.2g oil (along with white rice and light colored vegetables) on the first day of the study. Blood samples will be collected at 1 3, 7, 14, and 21 days after the study doses.
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.
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.
Eligibility| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy children
Exclusion Criteria:
- food allergy
- parasitic infection
Contacts and Locations| United States, Massachusetts | |
| USDA Human Nutrition Research Center on Aging, Tufts Uni. | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Guangwen Tang, Ph. D | Tufts University |
More Information
No publications provided by Tufts University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guangwen Tang, Tufts University |
| ClinicalTrials.gov Identifier: | NCT00680212 History of Changes |
| Other Study ID Numbers: | IRB 8458, R01DK60021 |
| Study First Received: | May 16, 2008 |
| Last Updated: | February 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
|
dietary beta-carotene vitamin A status intrinsically labeled plant foods |
Additional relevant MeSH terms:
|
Vitamin A Deficiency Night Blindness Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases Carotenoids Retinol palmitate Vitamin A Vitamins |
Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013