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Estimating Average Vitamin A Requirements in Indonesian and American Women

Development of 13C-Retinol Isotope Dilution Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04123210
Enrollment
70
Registered
2019-10-10
Start date
2008-03-17
Completion date
2009-05-05
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Deficiency

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.

Interventions

DIETARY_SUPPLEMENTVitamin A supplement
DIETARY_SUPPLEMENTPlacebo

Sponsors

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Participants blinded (Indonesian), double blinded (USA)

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).

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal nutritional status (BMI 18.5-25)

Exclusion criteria

* Significant clinical illness

Design outcomes

Primary

MeasureTime frameDescription
Total body vitamin A stores (micromoles of vitamin A)Baseline and after 42 to 60 daysChange 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 daysChange in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution

Countries

Indonesia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026