NCT06734611

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

December 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

December 10, 2024

Last Update Submit

March 9, 2026

Conditions

Folate DeficiencyNeural Tube Defects

Keywords

folic acidiodinesaltserum folatered blood cell folatepreventionfolate insufficiencyMalnutritionNervous System MalformationsSpinal DysraphismVitamin B9Micronutrients

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)

    1,3,6 months

  • Measure of folate insufficiency via serum and RBC concentration

    0-6 months

Study Arms (1)

FISFA arm

EXPERIMENTAL

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

Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA)

Interventions

Fortified Iodized Salt with Folic Acid (FISFA)DIETARY_SUPPLEMENT

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

FISFA arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Centre for Infectious Disease Research in Zambia

Lusaka, 10101, Zambia

Location

MeSH Terms

Conditions

Folic Acid DeficiencyNeural Tube DefectsMalnutritionNervous System MalformationsSpinal Dysraphism

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anastasia A Smith, DrPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia A Smith, DrPH

CONTACT

205-276-1067anastasia.arynchyna@childrensal.org

Anna Munger, MS

CONTACT

amunger@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 16, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Redacted information will be made available upon request.

Locations

ZA(1)US(1)