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Vitamin A Equivalence of Plant Carotenoids in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00680212
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Tufts University

Tracking Information
First Submitted Date  ICMJE May 16, 2008
First Posted Date  ICMJE May 20, 2008
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2008)
conversion efficiency of b-C to retinol [ Time Frame: up to 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00680212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin A Equivalence of Plant Carotenoids in Children
Official Title  ICMJE Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vitamin A Deficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE 1
dietary carotenoids
Interventions:
  • Dietary Supplement: dietary carotenoids
  • Dietary Supplement: spinach, rice, and synthetic beta-carotene
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 16, 2008)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy children

Exclusion Criteria:

  • food allergy
  • parasitic infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT00680212
Other Study ID Numbers  ICMJE IRB 8458
R01DK060021 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guangwen Tang, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guangwen Tang, Ph. D Tufts University
PRS Account Tufts University
Verification Date February 2009

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