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

Hypervitaminosis A Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915731
• Other study ID #: EC016-5/2015
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 23, 2016
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Medical Research Council, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 60 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypervitaminosis A

Intervention

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

Locations

Country	Name	City	State
South Africa	South African Medical Research Council	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
Medical Research Council, South Africa	International Atomic Energy Agency, University of Wisconsin, Madison

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No