Study Results
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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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2026-03-01
2026-12-31
Brief Summary
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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 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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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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FISFA arm
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
Fortified Iodized Salt with Folic Acid (FISFA)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Centre for Infectious Disease Research in Zambia
OTHER
Baylor College of Medicine
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Anastasia Smith
Clinical Research Manager
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
Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Countries
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Central Contacts
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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