Folic Acid Supplementation for Neural Tube Defects Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if salt fortified with folic acid can boost folate levels in women of childbearing age in Zambia. Participants will use this special salt instead of their regular salt for six months. The study will monitor folate levels through blood tests and surveys. Women who may be suitable are those who are neither pregnant nor nursing and can consistently use the special salt at home.
As an unphased trial, this study provides a unique opportunity to contribute to important nutritional research that could benefit women's health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that fortified iodized salt with folic acid is safe for consumption?
Research has shown that fortified iodized salt with folic acid (FISFA) is safe. Folic acid, or vitamin B9, is crucial for preventing serious birth defects like spina bifida and anencephaly. Studies have found that adding folic acid to foods, such as salt, effectively boosts folate levels in people. This is particularly important for women who might become pregnant, as it can reduce the risk of birth defects in future pregnancies.
No reports of serious side effects from adding folic acid to food suggest that FISFA is well-tolerated and a safe way to increase folate intake.12345Why are researchers excited about this trial?
Unlike the standard of care for preventing neural tube defects, which typically involves taking folic acid supplements directly, FISFA uses fortified iodized salt with folic acid as a delivery method. This novel approach integrates folic acid into a common dietary staple, ensuring wider, consistent consumption among populations who might not take regular supplements. Researchers are excited about FISFA because it could offer a more accessible and practical way to deliver essential nutrients, potentially improving compliance and reaching a larger number of individuals who need it most.
What evidence suggests that fortified iodized salt with folic acid is effective for increasing folate levels in women of reproductive age?
Research has shown that folic acid (vitamin B9) can help prevent serious birth defects like spina bifida and anencephaly, which affect the brain and spine. Adding folic acid to iodized salt effectively raises folate levels in the blood. This increase is crucial because higher folate levels can lower the risk of these birth defects. Studies suggest that fortifying foods with folic acid, such as enhanced salt, could prevent up to 65% of these cases. In this trial, participants will receive fortified iodized salt with folic acid (FISFA) to evaluate its effectiveness in boosting folate levels and reducing the risk of birth defects for women of childbearing age in areas without folic acid fortification.15678
Who Is on the Research Team?
Anastasia A Smith, DrPH
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for non-pregnant, non-lactating women of reproductive age in Zambia who usually don't consume folic acid-fortified foods. Participants will replace their regular salt with a special iodized salt fortified with folic acid for six months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume fortified iodized salt with folic acid for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fortified Iodized Salt with Folic Acid (FISFA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Centre for Infectious Disease Research in Zambia
Collaborator
Baylor College of Medicine
Collaborator