NCT02915731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

August 30, 2016

Last Update Submit

September 23, 2016

Conditions

Hypervitaminosis A

Keywords

Vitamin A storesStable isotope dilutionMultiple vitamin A interventions

Outcome Measures

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

    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

    4 weeks

Interventions

Vitamin A supplementDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age36 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South African Medical Research Council

Cape Town, 7505, South Africa

Location

Related Publications (5)

  • van Stuijvenberg ME, Schoeman SE, Lombard CJ, Dhansay MA. Serum retinol in 1-6-year-old children from a low socio-economic South African community with a high intake of liver: implications for blanket vitamin A supplementation. Public Health Nutr. 2012 Apr;15(4):716-24. doi: 10.1017/S1368980011002126. Epub 2011 Aug 23.

    PMID: 21859509BACKGROUND

  • Nel J, van Stuijvenberg ME, Schoeman SE, Dhansay MA, Lombard CJ, du Plessis LM. Liver intake in 24-59-month-old children from an impoverished South African community provides enough vitamin A to meet requirements. Public Health Nutr. 2014 Dec;17(12):2798-805. doi: 10.1017/S1368980013003212. Epub 2013 Nov 28.

    PMID: 24476795BACKGROUND

  • Tanumihardjo SA. Usefulness of vitamin A isotope methods for status assessment: from deficiency through excess. Int J Vitam Nutr Res. 2014;84 Suppl 1:16-24. doi: 10.1024/0300-9831/a000182.

    PMID: 25537102BACKGROUND

  • Sheftel J, van Stuijvenberg ME, Dhansay MA, Suri DJ, Grahn M, Keuler NS, Binkley NC, Tanumihardjo SA. Chronic and acute hypervitaminosis A are associated with suboptimal anthropometric measurements in a cohort of South African preschool children. Am J Clin Nutr. 2022 Apr 1;115(4):1059-1068. doi: 10.1093/ajcn/nqab422.

    PMID: 35030234DERIVED

  • van Stuijvenberg ME, Dhansay MA, Nel J, Suri D, Grahn M, Davis CR, Tanumihardjo SA. South African preschool children habitually consuming sheep liver and exposed to vitamin A supplementation and fortification have hypervitaminotic A liver stores: a cohort study. Am J Clin Nutr. 2019 Jul 1;110(1):91-101. doi: 10.1093/ajcn/nqy382.

    PMID: 31089689DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hypervitaminosis A

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Martha E van Stuijvenberg, PhD

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

  • Muhammad A Dhansay, FC Paed

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Specialist Scientist

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 27, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

ZA(1)