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Could adding folic acid to salt prevent birth defects in zambia?

NCT ID NCT06734611

Prevention Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study tests whether adding folic acid to iodized salt can raise folate levels in women of childbearing age in Zambia, a country without mandatory folic acid fortification. Two hundred fifty non-pregnant, non-lactating women aged 18–45 will use the fortified salt instead of regular salt for six months. Researchers will measure folate in blood samples at several points to see if levels increase enough to help prevent neural tube defects in future pregnancies.

What this could mean

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

Active substance
folic acid fortified iodized salt
What this could lead to
If effective, this simple salt fortification could offer an affordable way to prevent serious birth defects in countries without existing folic acid programs.
What could go wrong
This is a small, early-stage study (250 women) in one country. Results may not apply elsewhere, and the salt's taste or color might reduce long-term use.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2028

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 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Voluntary participation in the study * Do not intend to get pregnant * Not lactating or pregnant * Live alone or with a partner if they can be compliant and not share the study salt. * Aged between 18 and 45 years Exclusion Criteria: * Pregnant or lactating

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Conditions

The condition(s) this trial relates to.

central nervous system malformation Folic Acid Deficiency folic acid deficiency anemia Malnutrition neural tube defect spina bifida neural tube defects, susceptibility to prevention target

As listed by the trial registrant

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

Folate deficiency Neural tube defects

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Infectious Disease Research in Zambia

    RECRUITING

    Lusaka, 10101, Zambia

  • University of Alabama at Birmingham

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35294, United States

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