Back to resultsEstimating Average Vitamin A Requirements in Indonesian and American Women
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vitamin A supplement
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin A Deficiency
Eligibility Criteria
Inclusion Criteria:
- Normal nutritional status (BMI 18.5-25)
Exclusion Criteria:
- Significant clinical illness
Sites / Locations
- University of Wisconsin - Madison
- Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin A supplement
Placebo
Arm Description
Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily
Subjects receive an oil placebo containing no vitamin A
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04123210
First Posted
October 7, 2019
Last Updated
October 29, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT04123210
Brief Title
Estimating Average Vitamin A Requirements in Indonesian and American Women
Official Title
Development of 13C-Retinol Isotope Dilution Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 17, 2008 (Actual)
Primary Completion Date
May 5, 2009 (Actual)
Study Completion Date
May 5, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 to estimate how much vitamin A is needed to maintain nutrient balance in these women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Participants blinded (Indonesian), double blinded (USA)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin A supplement
Arm Type
Experimental
Arm Description
Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive an oil placebo containing no vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Total body vitamin A stores (micromoles of vitamin A)
Description
Change in total body stores of vitamin A before and after intervention, measured by retinol isotope dilution
Time Frame
Baseline and after 42 to 60 days
Title
Total vitamin A liver reserves (micromoles vitamin A per gram liver)
Description
Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution
Time Frame
Baseline and after 42 to 60 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal nutritional status (BMI 18.5-25)
Exclusion Criteria:
Significant clinical illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry A Tanumihardjo, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Facility Name
Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
City
Bogor
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32492125
Citation
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.
Results Reference
derived
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Estimating Average Vitamin A Requirements in Indonesian and American Women
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