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
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 |
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.
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
South Africa | South African Medical Research Council | Cape Town |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council, South Africa | International Atomic Energy Agency, University of Wisconsin, Madison |
South Africa,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04438200 -
Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults
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