Estimating Average Vitamin A Requirements in Indonesian and American Women

October 29, 2019 updated by: University of Wisconsin, Madison

Development of 13C-Retinol Isotope Dilution Techniques

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Bogor, Indonesia
        • Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal nutritional status (BMI 18.5-25)

Exclusion Criteria:

  • Significant clinical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin A supplement
Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily
Dietary supplement: Vitamin A supplement
Placebo Comparator: Placebo
Subjects receive an oil placebo containing no vitamin A
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and after 42 to 60 days
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
Baseline and after 42 to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

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

Investigators

  • Principal Investigator: Sherry A Tanumihardjo, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2008

Primary Completion (Actual)

May 5, 2009

Study Completion (Actual)

May 5, 2009

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2007-0324
  • A074600 (Other Identifier: UW- Madison)
  • AG&LSC/NUTRITIONAL SCI/NUTRITI (Other Identifier: UW, Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin A Deficiency

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe