NCT02915731

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

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 Vitamin A Fortified Staple Foods

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Medical Research Council, South Africa · Academic / Other
• Sex: All
• Age: 36 Months – 60 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hypervitaminosis A

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin A supplement	200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-09-27
• Last updated: 2016-09-27

Locations

1 site across 1 country: South Africa