ClinicalTrials.gg
CompletedNCT04123210Updated Oct 31, 2019

Estimating Average Vitamin A Requirements in Indonesian and American Women

An interventional study of Vitamin A supplement and Placebo in Vitamin A Deficiency, sponsored by University of Wisconsin, Madison. Completed at 2 sites in 2 countries. Open to female participants aged 19 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-31.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 11 years 6 months after the study started (first participant enrolled Mar 2008, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
19 Years to 30 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Vitamin A Deficiency with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Vitamin A Deficiency · United States.

Enrollment
8th of 12
70 · median 86
Started
2008
with 1 other
No phase
6 of 16
3 open now
Registered
10th of 16
by date
Lead sponsor
3 of 16
University of Wisconsin, Madison

Among the 16 studies in Vitamin A Deficiency with a site in United States, this one is the 8th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2008, is one of 6 with no phase, and was the 10th registered.

Vitamin A Deficiency

67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.

Browse Vitamin A Deficiency studies →

Open to participants now

5 of the 16 studies in Vitamin A Deficiency with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 19 Years to 30 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Vitamin A Deficiency with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Vitamin A Deficiency

Browse trials for

04

Who can participate

Ages eligible
19 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Normal nutritional status ( 18.5-25)

Exclusion criteria

Exclusion Criteria:

  • Significant clinical illness
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementVitamin A supplement
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and after 42 to 60 days

  2. 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

    Time frame: Baseline and after 42 to 60 days

07

Study locations

2 sites
  • University of Wisconsin - Madison
    Madison, Wisconsin 53706, United States
  • Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
    Bogor, Indonesia
08

References and documents

Publications

  • 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. PubMed 32492125 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2008 to primary completion in May 2009, 13 months.

Of 19 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2019
First posted
Oct 10, 2019
StartActual
Mar 17, 2008
Primary completionActual
May 5, 2009
CompletionActual
May 5, 2009
Last update
Oct 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04123210
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Responsible party
Sponsor
First posted
Oct 10, 2019
Start date
Mar 17, 2008
Primary completion
May 5, 2009
Completion
May 5, 2009
Last update
Oct 31, 2019

Study contacts

Sherry A Tanumihardjo, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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