Folate DeficiencyNCT06734611
Folic Acid Salt Study (FISFA Zambia)
A study testing Fortified Iodized Salt with Folic Acid (FISFA) in people with Folate Deficiency and Neural Tube Defects, run by University of Alabama at Birmingham at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Folate Deficiency, Neural Tube Defects
- What is being tested?
- Fortified Iodized Salt with Folic Acid (FISFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Anna Munger, MS contact
2 sites in 2 countries
United States1 site
- Active, not recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Zambia1 site, 1 recruiting
- Recruiting
Centre for Infectious Disease Research in Zambia
Lusaka, 10101
Albert Manasyan, MD, +260 976 448 994, Albert.Manasyan@cidrz.org
About this study
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
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
Read the 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.
- Conditions
- Folate Deficiency, Neural Tube Defects
- Being tested
- Fortified Iodized Salt with Folic Acid (FISFA)
- Keywords
- folic acid, iodine, salt, serum folate, red blood cell folate, prevention, folate insufficiency, Malnutrition, Nervous System Malformations, Spinal Dysraphism, Vitamin B9, Micronutrients
- Medical subject headings
- Folic Acid Deficiency, Neural Tube Defects, Malnutrition, Nervous System Malformations, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Iodized Salt with Folic Acid (FISFA)Dietary supplement
Addition of folic acid to iodized salt for daily consumption to assess folate levels.
| Study group | Role | What they receive |
|---|---|---|
| FISFA arm | Experimental | Dietary Supplement: fortified iodized salt with folic acid (FISFA) Receives: Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Evaluate folate blood levels pre and post intervention
Measured: 0-6 months
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Evaluate folate blood levels pre and post intervention
Measured: 0-6 months
Secondary outcomes (2)
Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)
Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)
Measured: 1,3,6 months
Measure of folate insufficiency via serum and RBC concentration
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
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folate DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Baylor College of Medicine
- Responsible party
- Principal investigator, Anastasia Smith, University of Alabama at Birmingham
- Investigators
- Anastasia A Smith, DrPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734611
- Sponsor's protocol ID
- IRB-300013997
- Other IDs
- FISFA-Zambia-2025
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Redacted information will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06734611
- Acronym / sponsor ID
- IRB-300013997
- Conditions
- Folate Deficiency, Neural Tube Defects
- Keywords
- folic acid, iodine, salt, serum folate, red blood cell folate, prevention, folate insufficiency, Malnutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Baylor College of Medicine
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FISFA arm | Experimental | Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA)Dietary Supplement: fortified iodized salt with folic acid (FISFA) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified Iodized Salt with Folic Acid (FISFA)Addition of folic acid to iodized salt for daily consumption to assess folate levels. | Dietary supplement | FISFA arm |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Redacted information will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Munger, MS contact
Anastasia A Smith, DrPH principal investigator
University of Alabama at Birmingham
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified Iodized Salt with Folic Acid (FISFA) in people with Folate Deficiency and Neural Tube Defects, run by University of Alabama at Birmingham at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia A Smith, DrPH (205-276-1067, anastasia.arynchyna@childrensal.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) (time frame: 0-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.