Estimating Average Vitamin A Requirements in Indonesian and American Women

Not Applicable

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin A supplement

• Registration Number: NCT04123210
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-17
• Primary Completion: 2009-05-05
• Study Completion: 2009-05-05
• Status Verified: 2019-10
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Normal nutritional status (BMI 18.5-25)

Exclusion Criteria

• Significant clinical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects receive an oil placebo containing no vitamin A
Vitamin A supplement	Vitamin A supplement	Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily

Primary Outcome Measures

Name	Time	Method
Total body vitamin A stores (micromoles of vitamin A)	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)	Baseline and after 42 to 60 days	Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution

Trial Locations

Locations (2)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States

Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik; 🇮🇩 Bogor, Indonesia