Estimating Average Vitamin A Requirements in Indonesian and American Women

Vitamin A Deficiency Clinical Trial

Official title:

Development of 13C-Retinol Isotope Dilution Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123210
• Other study ID #: H-2007-0324
• Secondary ID: A074600AG&LSC/NU
• Status: Completed
• Phase: N/A
• Start date: March 17, 2008
• Est. completion date: May 5, 2009

Study information

• Verified date: October 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 to estimate how much vitamin A is needed to maintain nutrient balance in these women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 5, 2009
• Est. primary completion date: May 5, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 30 Years

Eligibility

Inclusion Criteria:

• Normal nutritional status (BMI 18.5-25)

Exclusion Criteria:

• Significant clinical illness

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Dietary Supplement:
• Vitamin A supplement

• Placebo

Locations

Country	Name	City	State
Indonesia	Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik	Bogor
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Health Research and Development (NIHRD), Indonesia

Countries where clinical trial is conducted

United States,  Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and after 42 to 60 days
Primary	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	Baseline and after 42 to 60 days