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

September 23, 2016 updated by: Lize van Stuijvenberg, Medical Research Council, South Africa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa, 7505
        • South African Medical Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3-5 year-old children from a low socio-economic South African community where liver is frequently eaten

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome 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
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council, South Africa

Collaborators

University of Wisconsin, Madison
International Atomic Energy Agency

Investigators

  • Principal Investigator: Martha E van Stuijvenberg, PhD, Medical Research Council, South Africa
  • Principal Investigator: Muhammad A Dhansay, FC Paed, Medical Research Council, South Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC016-5/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypervitaminosis A

Clinical Trials on Vitamin A supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe