Retinol Equivalence of Plant Carotenoids in Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00082420
First received: May 6, 2004
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.

The experiments will be conducted in children (ages 7-9) with/without adequate 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, deca-deuterated retinyl acetate (RAc-d10), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo.

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 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.


Condition
Vitamin A Deficiency

Study Type: Observational
Study Design: Observational Model: Case-Only

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Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Enrollment: 32
Study Start Date: September 2004
Study Completion Date: November 2005
Detailed Description:

Seventy-two children each will take two meals, lunch and supper, containing equal amounts of ß-C in labeled spinach (along with white rice), or Golden Rice (along with light colored vegetables), or ß-C oil capsules (along with white rice and light colored vegetables), every day for 7 days. Before the two meals, the volunteers will take a breakfast with a RAc-d10 dose as a reference for 7 days. 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.

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy children with normal or marginal vitamin A nutrition

Criteria

Inclusion Criteria:

  • 7-9 years old

Exclusion Criteria:

  • Parasitic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00082420     History of Changes
Obsolete Identifiers: NCT00072696
Other Study ID Numbers: RETEQ (completed), DK60021
Study First Received: May 6, 2004
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Vitamin A malnutrition
low vitamin A status

Additional relevant MeSH terms:
Night Blindness
Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
Eye Diseases
Malnutrition
Nutrition Disorders
Vision Disorders

ClinicalTrials.gov processed this record on October 23, 2014