Folic Acid Salt Study (FISFA Zambia)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06734611
- Status
- Recruiting
Conditions
- Folate Deficiency
- Neural Tube Defects
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Fortified Iodized Salt with Folic Acid (FISFA) — DIETARY_SUPPLEMENTAddition of folic acid to iodized salt for daily consumption to assess folate levels.
Study Details
Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program? Participants will: * Consume salt with folic acid instead of their regular salt for 6 months * Have a blood draw 4 times * Fill out surveys
Key Dates
- First listed
- Dec 16, 2024
- Start date
- Apr 10, 2026
- Status verified
- Jun 2026
- Primary completion
- Apr 1, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: FISFA armDietary Supplement: fortified iodized salt with folic acid (FISFA)
Primary Outcome Measure
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) [ Time Frame: 0-6 months ]
Central Contacts
- Anastasia A Smith, DrPH205-276-1067
- Anna Munger, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | - |
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