Hypervitaminosis ANCT02915731
Total Body Vitamin A Before and After Vitamin A Supplementation in a Community Where Liver is Frequently Eaten
An observational study of Hypervitaminosis A, run by Medical Research Council, South Africa at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Ages 36 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Hypervitaminosis A
- What is being tested?
- Vitamin A supplement
- How many people
- 95 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3-5 year-old children from a low socio-economic South African community where liver is frequently eaten
Who may be able to join
- Living in the study area;
- Must not have received a vitamin A supplement in the preceding month
Who cannot join
- Severe anaemia (haemoglobin < 9 g/dL);
- Fever (body temperature > 38°C)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council
Cape Town, 7505
About this study
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
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.
Read the 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.
- Conditions
- Hypervitaminosis A
- Being tested
- Vitamin A supplement
- Keywords
- Vitamin A stores, Stable isotope dilution, Multiple vitamin A interventions
- Medical subject headings
- Hypervitaminosis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementDietary supplement
200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypervitaminosis AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Lize van Stuijvenberg, Medical Research Council, South Africa
- Investigators
- Martha E van Stuijvenberg, PhD, Principal investigator, Medical Research Council, South AfricaMuhammad A Dhansay, FC Paed, Principal investigator, Medical Research Council, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915731
- Sponsor's protocol ID
- EC016-5/2015
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21859509Nel 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.
PubMed 24476795Tanumihardjo 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.
PubMed 25537102Sheftel 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.
PubMed 35030234van 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.
PubMed 31089689
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02915731
- Acronym / sponsor ID
- EC016-5/2015
- Conditions
- Hypervitaminosis A
- Keywords
- Vitamin A stores, Stable isotope dilution, Multiple vitamin A interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Medical Research Council, South AfricaUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Wisconsin, Madison
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 36 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3-5 year-old children from a low socio-economic South African community where liver is frequently eaten
Key inclusion criteria (2 listed)
- Living in the study area;
- Must not have received a vitamin A supplement in the preceding month
Key exclusion criteria (2 listed)
- Severe anaemia (haemoglobin < 9 g/dL);
- Fever (body temperature > 38°C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A supplement200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program | Dietary supplement | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 21859509van 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.
- Background: PubMed 24476795Nel 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.
- Background: PubMed 25537102Tanumihardjo 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.
- Derived from this study: PubMed 35030234Sheftel 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.
- Derived from this study: PubMed 31089689van 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha E van Stuijvenberg, PhD principal investigator
Medical Research Council, South Africa
Muhammad A Dhansay, FC Paed principal investigator
Medical Research Council, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypervitaminosis A, run by Medical Research Council, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915731, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.