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Vitamin A Equivalence of Plant Carotenoids in Children

This study has been completed.
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00680212
First received: May 16, 2008
Last updated: February 17, 2009
Last verified: February 2009

May 16, 2008
February 17, 2009
July 2008
January 2009   (final data collection date for primary outcome measure)
conversion efficiency of b-C to retinol [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680212 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Vitamin A Equivalence of Plant Carotenoids in Children
Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN

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 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Vitamin A Deficiency
  • 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
1
dietary carotenoids
Interventions:
  • Dietary Supplement: dietary carotenoids
  • Dietary Supplement: spinach, rice, and synthetic beta-carotene
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy children

Exclusion Criteria:

  • food allergy
  • parasitic infection
Both
6 Years to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680212
IRB 8458, R01DK60021
Yes
Guangwen Tang, Tufts University
Tufts University
Not Provided
Principal Investigator: Guangwen Tang, Ph. D Tufts University
Tufts University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP