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Vitamin A Equivalence of Plant Carotenoids in Children

Primary Purpose

Vitamin A Deficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dietary carotenoids
spinach, rice, and synthetic beta-carotene
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin A Deficiency focused on measuring dietary beta-carotene, vitamin A status, intrinsically labeled plant foods

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy children

Exclusion Criteria:

  • food allergy
  • parasitic infection

Sites / Locations

  • USDA Human Nutrition Research Center on Aging, Tufts Uni.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

dietary carotenoids

Outcomes

Primary Outcome Measures

conversion efficiency of b-C to retinol

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
February 17, 2009
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT00680212
Brief Title
Vitamin A Equivalence of Plant Carotenoids in Children
Official Title
Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
dietary beta-carotene, vitamin A status, intrinsically labeled plant foods

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
dietary carotenoids
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary carotenoids
Intervention Description
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
spinach, rice, and synthetic beta-carotene
Other Intervention Name(s)
dietary carotenoids
Intervention Description
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
Primary Outcome Measure Information:
Title
conversion efficiency of b-C to retinol
Time Frame
up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy children Exclusion Criteria: food allergy parasitic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangwen Tang, Ph. D
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Human Nutrition Research Center on Aging, Tufts Uni.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22854406
Citation
Tang G, Hu Y, Yin SA, Wang Y, Dallal GE, Grusak MA, Russell RM. beta-Carotene in Golden Rice is as good as beta-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.
Results Reference
derived

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Vitamin A Equivalence of Plant Carotenoids in Children

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