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NCT06734611NARecruitingAccepts Healthy Volunteers

Folic Acid Salt Study (FISFA Zambia)

University of Alabama at Birmingham

Start Date

4/10/2026

Completion Date

12/31/2028

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.

Eligibility Criteria

Age Range: 18 years to 45 years

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

Interventions

DIETARY_SUPPLEMENT

Fortified Iodized Salt with Folic Acid (FISFA)

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Conditions

Folate DeficiencyNeural Tube Defects

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Centre for Infectious Disease Research in Zambia

Lusaka, 10101

Zambia