NCT06734611

Folic Acid Salt Study (FISFA Zambia)

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Folate Deficiency
• Neural Tube Defects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fortified Iodized Salt with Folic Acid (FISFA)	Addition of folic acid to iodized salt for daily consumption to assess folate levels.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-16
• Last updated: 2026-03-11

Locations

2 sites across 2 countries: United States, Zambia