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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02915731

Enrollment

Registered

2016-09-27

Start date

2016-04-30

Completion date

2016-06-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypervitaminosis A

Keywords

Vitamin A stores, Stable isotope dilution, Multiple vitamin A interventions

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.

Interventions

DIETARY_SUPPLEMENTVitamin A supplement

200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

36 Months to 60 Months

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026