Estimating Average Vitamin A Requirements in Indonesian and American Women

NCT04123210 | Completed

• 3 other identifiers: H-2007-0324A074600AG&LSC/NUTRITIONAL SCI/NUTRITI
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

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.

Conditions

Vitamin A Deficiency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Vitamin A supplement

EXPERIMENTAL

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

Dietary Supplement: Vitamin A supplement

Placebo

PLACEBO COMPARATOR

Subjects receive an oil placebo containing no vitamin A

Dietary Supplement: Placebo

Interventions

Vitamin A supplement DIETARY_SUPPLEMENT

Vitamin A supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal nutritional status (BMI 18.5-25)

You may not qualify if:

• Significant clinical illness

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator

Study Sites (2)

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik

Bogor, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 32492125 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sherry A Tanumihardjo, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants blinded (Indonesian), double blinded (USA)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: March 17, 2008
• Primary Completion: May 5, 2009
• Study Completion: May 5, 2009
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ID (1)