Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
FISFA arm
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
Intervention: Fortified Iodized Salt with Folic Acid (FISFA) (Dietary Supplement)
Outcomes
Primary Outcomes
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Time Frame: 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)
Time Frame: 0-6 months
Evaluate folate blood levels pre and post intervention
Secondary Outcomes
- 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)
Investigators
Anastasia Smith
Clinical Research Manager
University of Alabama at Birmingham