Clinical Trial: Total Body Vitamin A Before and After Vitamin A Supplementation in a Community Where Liver is Frequently Eaten

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Total Body Vitamin A Pool Size in Preschool Children Before and After Vitamin A Supplementation in an Impoverished South African Community Where Liver is Frequently Eaten and Children Exposed to Vitam

Brief Summary: This study will assess total body vitamin A pool size, as well as liver vitamin A stores, by means of stable isotope dilution in preschool children from a South African community where liver, an exceptionally rich source of vitamin A, is frequently eaten, and the children exposed to vitamin A fortified staple foods, as well as a vitamin A supplementation programme.

Detailed Summary: Serum retinol, the most commonly used indicator to assess vitamin A status, is homeostatically controlled and, although it is able to detect deficiency, it does not necessarily reflect liver stores or measure excessive vitamin A intake. The stable isotope dilution method is able to measure total vitamin A body pool size over the vitamin A status continuum, including the sub-toxic range,and would add valuable information about the vitamin A status in a community where liver (an exceptionally rich source of vitamin A) is frequently eaten, and children also exposed to other vitamin A interventions. Total body vitamin A will be assessed before and 4 weeks after a high dose vitamin A supplement given to the children as part of the national vitamin A supplementation program. The confounding effect of infection/inflammation on the biomarkers of vitamin A status will also be examined, as well as how serum retinol and retinol binding protein relate to each other, and to vitamin A pool size.
Sponsor: Medical Research Council, South Africa

Current Primary Outcome: Number of participants with total body vitamin A stores in the sub-toxic range as measured by stable isotope dilution using 13C-retinol as tracer [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with elevated inflammation markers, as measured by elevated C-reactive protein (CRP) and alpha-1-acid glycoprotein (AGP), and their confounding effect on serum retinol, retinol binding protein, and body vitamin A stores [ Time Frame: 4 weeks ]

Original Secondary Outcome: Same as current

Information By: Medical Research Council, South Africa

Dates:
Date Received: August 30, 2016
Date Started: April 2016
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016