Folic Acid Salt Study (FISFA Zambia)

NCT ID: NCT06734611

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Folate Deficiency Neural Tube Defects

Keywords

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folic acid iodine salt serum folate red blood cell folate prevention folate insufficiency Malnutrition Nervous System Malformations Spinal Dysraphism Vitamin B9 Micronutrients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FISFA arm

Dietary Supplement: fortified iodized salt with folic acid (FISFA)

Group Type EXPERIMENTAL

Fortified Iodized Salt with Folic Acid (FISFA)

Intervention Type DIETARY_SUPPLEMENT

Addition of folic acid to iodized salt for daily consumption to assess folate levels.

Interventions

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Fortified Iodized Salt with Folic Acid (FISFA)

Addition of folic acid to iodized salt for daily consumption to assess folate levels.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Anastasia Smith

Clinical Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anastasia A Smith, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Centre for Infectious Disease Research in Zambia

Lusaka, , Zambia

Site Status

Countries

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United States Zambia

Central Contacts

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Anastasia A Smith, DrPH

Role: CONTACT

Phone: 205-276-1067

Email: [email protected]

Anna Munger, MS

Role: CONTACT

Email: [email protected]

Facility Contacts

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Albert Manasyan, MD

Role: primary

Other Identifiers

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FISFA-Zambia-2025

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300013997

Identifier Type: -

Identifier Source: org_study_id