An interventional study of Fortified Iodized Salt with Folic Acid (FISFA) in Folate Deficiency and Neural Tube Defects, sponsored by University of Alabama at Birmingham. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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:
The objective of this nonrandomized controlled intervention trial is to measure the effectiveness of fortified iodized salt with folic acid (FISFA) on increasing blood folate concentrations as a preventive measure against folate-sensitive neural tube defects (NTDs) in a non-fortifying country of Zambia.
The main questions it aims to answer are:
Aim 1: Measure the effectiveness of FISFA on increasing serum and red blood cell folate concentrations in women of reproductive age in a non-fortifying country.
Aim 2: Assess the risk of neural tube defects by measuring folate insufficiency levels via serum and red blood cell concentrations in women of reproductive age in a non-fortifying country.
Aim 3: Assess taste and color acceptability of FISFA by study population.
32 studies on the registry are indexed under Folic Acid Deficiency; 3 are open to participants now.
This study's planned enrollment of 250 is above the median of 90 across 15 interventional studies indexed under Folic Acid Deficiency.
Browse Folic Acid Deficiency studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA)
Addition of folic acid to iodized salt for daily consumption to assess folate levels.
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Evaluate folate blood levels pre and post intervention
Time frame: 0-6 months
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Evaluate folate blood levels pre and post intervention
Time frame: 0-6 months
Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)
Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)
Time frame: 1,3,6 months
Measure of folate insufficiency via serum and RBC concentration
Comparing folate insufficiency via serum and RBC concentration to recommended levels of 25.5 nmol/L (serum) and 906 nmol/L in RBC for WRA
Time frame: 0-6 months
Not enrolling at this site.
Plan to share: No — Redacted information will be made available upon request.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.
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