Clinical trial Recruiting at 1 site Interventional Ages 18 to 45 Women only

Folic Acid–Fortified Salt for Women of Reproductive Age in Zambia

Official title: Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country

Run by University of Alabama at Birmingham · NCT06734611 · Data updated 2026-11-12

This study tests whether iodized salt fortified with folic acid can raise blood folate levels in non-pregnant, non-lactating women in Zambia who don’t have a folic acid fortification program.

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Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment250 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations2 sites (Birmingham, Alabama and 1 other locations)
StatusRecruiting
StartedApril 10, 2026
Main results expectedApril 1, 2027
Study endsDecember 31, 2028
Registry record updatedJune 29, 2026
Trial IDNCT06734611 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18–45 in Zambia who are non-pregnant, non-lactating, not planning pregnancy, and who can use only the study salt.

Probably not a fit

Pregnant or lactating women, those planning pregnancy soon, or individuals unable to adhere to using only the study salt may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nonrandomized intervention gives participants salt fortified with folic acid to replace their regular salt for six months. Researchers measure serum and red blood cell folate four times and collect survey data to evaluate acceptability. The study aims to see if FISFA increases folate levels and could reduce folate-related neural tube defect risk, while also monitoring taste and color acceptability. Participants must meet age and pregnancy status criteria and agree not to share study salt. The trial is conducted through collaboration between the University of Alabama at Birmingham and Zambian partners.

Why it matters

Potential benefit: If successful, fortified salt could raise folate levels in reproductive-age women and potentially reduce neural tube defect risk.

How similar studies have gone: Prior fortified salt approaches have shown potential in raising folate status in populations, but results vary by context and fortification level.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Centre for Infectious Disease Research in Zambia
    Lusaka, Zambia
    Recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Active not recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.