Vitamin A Equivalence of Plant Carotenoids in Children

• ClinicalTrials.gov Identifier: NCT00680212
• Recruitment Status: Completed
• First Posted: May 20, 2008
• Last Update Posted: February 18, 2009
• Sponsor: Tufts University
• Information provided by: Tufts University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitamin A Deficiency	Dietary Supplement: dietary carotenoids; Dietary Supplement: spinach, rice, and synthetic beta-carotene	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN
• Study Start Date: July 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. conversion efficiency of b-C to retinol [ Time Frame: up to 21 days ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• healthy children

Exclusion Criteria:

• food allergy
• parasitic infection

Contacts and Locations

Locations

United States, Massachusetts

USDA Human Nutrition Research Center on Aging, Tufts Uni.

Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts University

Investigators

• Principal Investigator: Guangwen Tang, Ph. D; Tufts University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tang G, Hu Y, Yin SA, Wang Y, Dallal GE, Grusak MA, Russell RM. β-Carotene in Golden Rice is as good as β-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. Retraction in: Am J Clin Nutr. 2015 Sep;102(3):715.

Retraction in: Am J Clin Nutr. 2015 Sep;102(3):715

• Responsible Party: Guangwen Tang, Tufts University
• ClinicalTrials.gov Identifier: NCT00680212
• Other Study ID Numbers: IRB 8458; R01DK060021 ( U.S. NIH Grant/Contract )
• First Posted: May 20, 2008
• Last Update Posted: February 18, 2009
• Last Verified: February 2009

Keywords provided by Tufts University:

dietary beta-carotene; vitamin A status; intrinsically labeled plant foods

Additional relevant MeSH terms:

Vision Disorders; Night Blindness; Vitamin A Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Eye Diseases; Beta Carotene; Carotenoids; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Provitamins; Vitamins; Micronutrients; Nutrients; Growth Substances