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

Completed

• Conditions: Hypervitaminosis A

• Registration Number: NCT02915731
• Lead Sponsor: Medical Research Council, South Africa

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 Description

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.

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-30
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-23
• Last Update Submitted: 2016-09-23
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Living in the study area;
• Must not have received a vitamin A supplement in the preceding month

Exclusion Criteria

• Severe anaemia (haemoglobin < 9 g/dL);
• Fever (body temperature > 38°C)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	4 weeks

Secondary Outcome Measures

Name	Time	Method
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	4 weeks

Trial Locations

Locations (1)

South African Medical Research Council; 🇿🇦 Cape Town, South Africa