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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT06734611 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
- Principal investigator: Anastasia A Smith, DrPH — University of Alabama at Birmingham
- Study coordinator: Anastasia A Smith, DrPH
- Email: anastasia.arynchyna@childrensal.org
- Phone: 205-276-1067
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fetoscopic repair of neural tube defects
This study looks at how well a special surgery done before birth can help babies with spina bifida and what happens to them after the procedure.
-
Evaluating devices for repairing neural tube defects in fetoscopic procedures
This study is testing new tools to see if they make it safer and easier to fix neural tube defects in unborn babies during a special type of surgery.
-
Comparing two surgical methods for correcting fetal myelomeningocele
This study is testing two different surgical methods to see which one works better and is safer for fixing a serious birth defect called fetal myelomeningocele before the baby is born.
-
Evaluating patterns in neurodevelopmental disorders
This study is trying to find common signs and causes of neurodevelopmental disorders like Autism and Down Syndrome to help with earlier diagnosis and better outcomes for those affected.
-
First-Trimester Screening for Open Neural Tube Defects with Fetal Biometrics and Maternal Markers
This study tests whether early ultrasound measures and maternal blood markers can help screen for open neural tube defects in the first trimester.
-
FRα expression in high-grade serous ovarian cancer (FRα positive)
A retrospective study in Greece will test how often Folate Receptor Alpha is present in tumor samples from adults diagnosed with high-grade serous ovarian cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.