Vitamin A DeficiencyNCT04123210
Estimating Average Vitamin A Requirements in Indonesian and American Women
A study testing Vitamin A supplement in people with Vitamin A Deficiency, run by University of Wisconsin, Madison at 2 sites in 2 countries.
Trial summary
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group… Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Vitamin A supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Mar 2008to 5 May 2009
- Phase
- Interventional
- 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 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal nutritional status (BMI 18.5-25)
Who cannot join
- Significant clinical illness
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53706
Indonesia1 site
Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
Bogor
About this study
Official title: Development of 13C-Retinol Isotope Dilution Techniques
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.
- Conditions
- Vitamin A Deficiency
- Being tested
- Vitamin A supplement, Placebo
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A supplement | Experimental | Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily Receives: Dietary Supplement: Vitamin A supplement |
| Placebo | Placebo comparator | Subjects receive an oil placebo containing no vitamin A Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body vitamin A stores (micromoles of vitamin A)
Change in total body stores of vitamin A before and after intervention, measured by retinol isotope dilution
Measured: Baseline and after 42 to 60 days
Total vitamin A liver reserves (micromoles vitamin A per gram liver)
Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution
Measured: Baseline and after 42 to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start17 Mar 2008
- Primary completion5 May 2009
- Study completion5 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Sponsor
- Investigators
- Sherry A Tanumihardjo, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123210
- Sponsor's protocol ID
- H-2007-0324
- Other IDs
- A074600, AG&LSC/NUTRITIONAL SCI/NUTRITI
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sheftel J, Valentine AR, Hull AK, Fadjarwati T, Gannon BM, Davis CR, Tanumihardjo SA. Findings in 3 clinical trials challenge the accuracy of the Institute of Medicine's estimated average requirements for vitamin A in children and women. Am J Clin Nutr. 2021 May 8;113(5):1322-1331. doi: 10.1093/ajcn/nqaa132.
PubMed 32492125
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of 13C-Retinol Isotope Dilution Techniques
- ClinicalTrials.gov ID
- NCT04123210
- Acronym / sponsor ID
- H-2007-0324
- Conditions
- Vitamin A Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 17 Mar 2008 (actual)
- Primary completion
- 5 May 2009 (actual)
- Study completion
- 5 May 2009 (actual)
- First posted
- 10 Oct 2019 (actual)
- 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.
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).
| Arm | Type | Receives |
|---|---|---|
| Vitamin A supplement | Experimental | Dietary Supplement: Vitamin A supplementSubjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects receive an oil placebo containing no vitamin A |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal nutritional status (BMI 18.5-25)
Key exclusion criteria (1 listed)
- Significant clinical illness
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 supplement | Dietary supplement | Vitamin A supplement |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Total body vitamin A stores (micromoles of vitamin A)
Time frame: Baseline and after 42 to 60 days
Change in total body stores of vitamin A before and after intervention, measured by retinol isotope dilution
Total vitamin A liver reserves (micromoles vitamin A per gram liver)
Time frame: Baseline and after 42 to 60 days
Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution
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 31 Oct 2019.
- Derived from this study: PubMed 32492125Sheftel J, Valentine AR, Hull AK, Fadjarwati T, Gannon BM, Davis CR, Tanumihardjo SA. Findings in 3 clinical trials challenge the accuracy of the Institute of Medicine's estimated average requirements for vitamin A in children and women. Am J Clin Nutr. 2021 May 8;113(5):1322-1331. doi: 10.1093/ajcn/nqaa132.
- Individual participant dataSharing planned: No
Related trials for Vitamin A Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Sherry A Tanumihardjo, PhD principal investigator
University of Wisconsin, Madison
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A supplement in people with Vitamin A Deficiency, run by University of Wisconsin, Madison at 2 sites in 2 countries.
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 1 inclusion and 1 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Indonesia. 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. Some participants in this study may receive a placebo. 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?
Total body vitamin A stores (micromoles of vitamin A) (time frame: Baseline and after 42 to 60 days). The study lists 2 primary outcomes in all. 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 NCT04123210, which also lists 1 linked publication.
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 31 Oct 2019.