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Vitamin Supplement
Folic Acid Salt Study (FISFA Zambia)
N/A
Waitlist Available
Led By Anastasia A Smith, DrPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Voluntary participation in the study
* Do not intend to get pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,3,6 months
Awards & highlights
No Placebo-Only Group
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
Eligible Conditions
- Tethered Cord Syndrome
- Anemia
- Neural Tube Defects
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1,3,6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,3,6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
Secondary study objectives
Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)
Measure of folate insufficiency via serum and RBC concentration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: FISFA armExperimental Treatment1 Intervention
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,654 Previous Clinical Trials
2,443,631 Total Patients Enrolled
Centre for Infectious Disease Research in ZambiaOTHER
45 Previous Clinical Trials
77,794 Total Patients Enrolled
Baylor College of MedicineOTHER
1,027 Previous Clinical Trials
6,029,872 Total Patients Enrolled
Anastasia A Smith, DrPHPrincipal InvestigatorUniversity of Alabama at Birmingham