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Study aims to fix One-Size-Fits-All vitamin guidelines for undernourished women

NCT ID NCT06081114

Knowledge-focused Sponsor: Johns Hopkins Bloomberg School of Public Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests different doses of a vitamin-and-mineral-fortified food supplement in 643 women in Bangladesh, including those who are pregnant. The goal is to find the minimum dose needed to correct nutritional deficiencies, since current daily recommendations are based on healthy people in wealthy countries. Researchers will measure nutrient levels in blood and urine over several months to see what works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
micronutrient supplement (balanced energy and protein supplement fortified with vitamins and minerals)
What this could lead to
If successful, this study could help set better daily recommended amounts of vitamins and minerals for women in low-income settings, improving nutrition guidelines worldwide.
What could go wrong
This is an early-stage dose-finding study, not a treatment trial. It may not lead to immediate health improvements, and results may not apply to other populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

643 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Either * Women (non-pregnant and non-lactating) and not planning a pregnancy in the next 6 months OR * Pregnant women (gestational age at enrollment of 12-14 weeks) Exclusion Criteria: * Eligible women not consenting to participate * Based on point-of-care clinical indicators after enrollment and prior to starting the intervention that is indicative of pre-existing liver or kidney conditions and severe anemia

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Micronutrient status

Contacts and locations

Locations

  • JiVitA Project

    Rangpur City, Bangladesh

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