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OpenTrials
Completed

NCT Number: NCT04123210

Estimating Average Vitamin A Requirements in Indonesian and American Women

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.

Completed

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Key information

Conditions

Vitamin A Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

19 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik, Bogor, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal nutritional status (BMI 18.5-25)

Exclusion criteria

  • Significant clinical illness

Treatment and study plan

Vitamin A supplement

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Registry information

Official study title

Development of 13C-Retinol Isotope Dilution Techniques

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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