Folic Acid Salt Study (FISFA Zambia)

Not Applicable

Not yet recruiting

• Conditions: Folate Deficiency; Neural Tube Defects

• Registration Number: NCT06734611
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Study Start: 2025-07-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)	0-6 months	Evaluate folate blood levels pre and post intervention
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)	0-6 months	Evaluate folate blood levels pre and post intervention

Secondary Outcome Measures

Name	Time	Method
Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)	1,3,6 months	Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)
Measure of folate insufficiency via serum and RBC concentration	0-6 months	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

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia