Folic Acid Salt Study (FISFA Zambia)
- Conditions
- Registration Number
- NCT06734611
- Lead Sponsor
- University of Alabama at Birmingham
- 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:
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- 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:
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- 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
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) 0-6 months Evaluate folate blood levels pre and post intervention
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint) 0-6 months Evaluate folate blood levels pre and post intervention
- Secondary Outcome Measures
Name Time Method Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale) 1,3,6 months Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)
Measure of folate insufficiency via serum and RBC concentration 0-6 months 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
Trial Locations
- Locations (2)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Centre for Infectious Disease Research in Zambia
🇿🇲Lusaka, Zambia