Folic Acid Supplementation for Neural Tube Defects Prevention

Recruiting at 1 trial location

Overseen By Anna Munger, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnant, Lactating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Fortified Iodized Salt with Folic Acid (FISFA) for preventing neural tube defects?

Research shows that folic acid, a key component of FISFA, is effective in reducing the risk of neural tube defects (NTDs) when taken by mothers around the time of conception. Studies have demonstrated that folic acid supplementation and fortification can significantly decrease the prevalence of NTDs in various regions. ^{1 2 3 4 5}

Is folic acid supplementation generally safe for humans?

Folic acid supplementation is generally considered safe for humans, but there are some concerns about potential adverse effects. High doses of folic acid may mask vitamin B12 deficiency, which can lead to nerve damage, and there are questions about its impact on colorectal cancer and immune function. However, these concerns are mostly based on studies in elderly populations and may not apply to everyone. ^{6 7 8 9 10}

How is the treatment Fortified Iodized Salt with Folic Acid (FISFA) different from other treatments for preventing neural tube defects?

Fortified Iodized Salt with Folic Acid (FISFA) is unique because it combines folic acid with iodized salt, making it a convenient way to deliver essential nutrients through a common dietary item, unlike traditional folic acid supplements that are taken as pills. This approach can help ensure more consistent intake of folic acid, especially in populations where supplement adherence is low. ^{11 12 13 14 15}

Research Team

Anastasia A Smith, DrPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Voluntary participation in the study

Not intending to get pregnant

Not lactating or pregnant

Exclusion Criteria

Pregnant or lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume fortified iodized salt with folic acid for 6 months

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fortified Iodized Salt with Folic Acid (FISFA)

Trial Overview The study tests if using iodized salt fortified with folic acid can increase blood folate levels in the participants. They'll use this special salt instead of regular one and have their blood tested four times over half a year to track changes.

Participant Groups

Group I: FISFA arm Experimental Treatment 1 Intervention

Dietary Supplement: fortified iodized salt with folic acid (FISFA)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Centre for Infectious Disease Research in Zambia

Collaborator

Trials

51

Recruited

90,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Long term maintenance of neural tube defects prevention in a high prevalence state. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Orofacial Clefts in High Prevalence Area of Birth Defects - Five Counties, Shanxi Province, China, 2000-2020. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Modeling shows high potential of folic acid-fortified salt to accelerate global prevention of major neural tube defects. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

When folic acid fails: Insights from 20 years of neural tube defect surveillance in South Carolina. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Periconceptional Folic Acid Use and Its Effects on Neural Tube Defects - Five Counties, Shanxi Province, China, 2010-2016. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Folic Acid and the Prevention of Birth Defects: 30 Years of Opportunity and Controversies. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Will increasing folic acid in fortified grain products further reduce neural tube defects without causing harm?: consideration of the evidence. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pros and cons of increasing folic acid and vitamin B12 intake by fortification. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Prospects for prevention of neural tube defects by vitamin supplementation. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Folic acid intake and spina bifida in the era of dietary folic acid fortification. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Gestational Folate and Folic Acid Intake among Women in Canada at Higher Risk of Pre-Eclampsia. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of periconceptional supplementation of folic acid. [2019]

13. Argentina pubmed.ncbi.nlm.nih.gov

[Folic acid for neural tube defects prevention: consumption and information in fertil-age women in Centro Cuyo Region]. [2014]

14. Chile pubmed.ncbi.nlm.nih.gov

[Effects of folic acid fortification in the rates of malformations at birth in Chile]. [2019]

15. Australia pubmed.ncbi.nlm.nih.gov

Neural tube defects: prevalence, etiology and prevention. [2022]