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Completed

NCT Number: NCT02915731

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

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.

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Key information

Age range

36 month–60 month

Sex eligibility

All sexes

Study type

Observational

Primary location

South African Medical Research Council

Cape Town, 7505, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin A supplement

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical Research Council, South Africa

Other

Collaborators

  • International Atomic Energy Agency
  • University of Wisconsin, Madison

Registry information

Official study 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 Vitamin A Fortified Staple Foods

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2016
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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