Folic Acid Salt Study (FISFA Zambia)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fortified Iodized Salt with Folic Acid (FISFA).
- Who it may be relevant to
- Registry conditions: Folate Deficiency, Neural Tube Defects. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country
Overview
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.
Interventions
- Dietary supplement Fortified Iodized Salt with Folic Acid (FISFA)
Addition of folic acid to iodized salt for daily consumption to assess folate levels.
Primary outcome measures
- Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) [Time frame: 0-6 months]
- Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint) [Time frame: 0-6 months]
Secondary outcome measures (2)
- Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale) [Time frame: 1,3,6 months]
- Measure of folate insufficiency via serum and RBC concentration [Time frame: 0-6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Zambia · 1 center
- Centre for Infectious Disease Research in Zambia — Lusaka
Identifiers
NCT: NCT06734611 · IRB-300013997 · FISFA-Zambia-2025