Development of 13C-Retinol Isotope Dilution Techniques

Estimating Average Vitamin A Requirements in Indonesian and American Women

Sponsors

Lead sponsor: University of Wisconsin, Madison

Collaborator: National Institute of Health Research and Development (NIHRD), Indonesia

Source University of Wisconsin, Madison
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.

Overall Status Completed
Start Date March 17, 2008
Completion Date May 5, 2009
Primary Completion Date May 5, 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Total body vitamin A stores (micromoles of vitamin A) Baseline and after 42 to 60 days
Total vitamin A liver reserves (micromoles vitamin A per gram liver) Baseline and after 42 to 60 days
Enrollment 70
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Vitamin A supplement

Arm group label: Vitamin A supplement

Intervention type: Dietary Supplement

Intervention name: Placebo

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Normal nutritional status (BMI 18.5-25)

Exclusion Criteria:

- Significant clinical illness

Gender: Female

Minimum age: 19 Years

Maximum age: 30 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sherry A Tanumihardjo, PhD Principal Investigator University of Wisconsin, Madison
Location
facility
University of Wisconsin - Madison | Madison, Wisconsin, 53706, United States
Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik | Bogor, Indonesia
Location Countries

Indonesia

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Vitamin A supplement

Arm group type: Experimental

Description: Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Subjects receive an oil placebo containing no vitamin A

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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).

Primary purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

Masking description: Participants blinded (Indonesian), double blinded (USA)

Source: ClinicalTrials.gov