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Estimating Average Vitamin A Requirements in Indonesian and American Women

NCT ID: NCT04123210

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-17

Study Completion Date

2009-05-05

Brief Summary

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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

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Conditions

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Vitamin A Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants blinded (Indonesian), double blinded (USA)

Study Groups

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Vitamin A supplement

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

Group Type EXPERIMENTAL

Vitamin A supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects receive an oil placebo containing no vitamin A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin A supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Normal nutritional status (BMI 18.5-25)

Exclusion Criteria

* Significant clinical illness
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherry A Tanumihardjo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik

Bogor, , Indonesia

Site Status

Countries

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United States Indonesia

References

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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.

Reference Type DERIVED
PMID: 32492125 (View on PubMed)

Other Identifiers

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A074600

Identifier Type: OTHER

Identifier Source: secondary_id

AG&LSC/NUTRITIONAL SCI/NUTRITI

Identifier Type: OTHER

Identifier Source: secondary_id

H-2007-0324

Identifier Type: -

Identifier Source: org_study_id