Folic Acid Salt Study (FISFA Zambia)
Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anastasia A Smith, DrPH
- Phone Number: 205-276-1067
- Email: anastasia.arynchyna@childrensal.org
Study Contact Backup
- Name: Anna Munger, MS
- Email: amunger@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Active, not recruiting
- University of Alabama at Birmingham
-
-
-
-
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Lusaka, Zambia, 10101
- Recruiting
- Centre for Infectious Disease Research in Zambia
-
Contact:
- Albert Manasyan, MD
- Phone Number: +260 976 448 994
- Email: Albert.Manasyan@cidrz.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FISFA arm
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
|
Addition of folic acid to iodized salt for daily consumption to assess folate levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
Evaluate folate blood levels pre and post intervention
|
0-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)
Time Frame: 1,3,6 months
|
Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)
|
1,3,6 months
|
|
Measure of folate insufficiency via serum and RBC concentration
Time Frame: 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
|
0-6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anastasia A Smith, DrPH, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Nutrition Disorders
- Congenital Abnormalities
- Avitaminosis
- Deficiency Diseases
- Vitamin B Deficiency
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Malnutrition
- Spinal Dysraphism
- Neural Tube Defects
- Folic Acid Deficiency
- Nervous System Malformations
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pterins
- Pteridines
- Folic Acid
Other Study ID Numbers
- IRB-300013997
- FISFA-Zambia-2025 (Other Identifier: University of Alabama at Birmingham)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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