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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Folate Deficiency; Neural Tube Defects
• Intervention / Treatment: Dietary supplement: Fortified Iodized Salt with Folic Acid (FISFA)

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anastasia A Smith, DrPH; Phone Number: 205-276-1067; Email: anastasia.arynchyna@childrensal.org
• Study Contact Backup: Name: Anna Munger, MS; Email: amunger@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
• Zambia
  • Lusaka, Zambia, 10101
    • Centre for Infectious Disease Research in Zambia
    • Contact: Albert Manasyan, MD; Phone Number: +260 976 448 994; Email: Albert.Manasyan@cidrz.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FISFA arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	0-6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Baylor College of Medicine; Centre for Infectious Disease Research in Zambia
• Investigators: Principal Investigator: Anastasia A Smith, DrPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Micronutrients; prevention; Malnutrition; iodine; salt; folic acid; Nervous System Malformations; Vitamin B9; Spinal Dysraphism; serum folate; red blood cell folate; folate insufficiency
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Congenital Abnormalities; Avitaminosis; Deficiency Diseases; Vitamin B Deficiency; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Malnutrition; Spinal Dysraphism; Neural Tube Defects; Folic Acid Deficiency; Nervous System Malformations; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Folic Acid
• Other Study ID Numbers: IRB-300013997; FISFA-Zambia-2025 (Other Identifier: University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Redacted information will be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No