Folic Acid for Arsenic Poisoning

Overseen By Crystal T Stephens, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Methotrexate

Disqualifiers: Pregnancy, Megaloblastic anemia, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effects on folic acid supplementation in a population living in an environment with chronic arsenic exposure in Birmingham, Alabama.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using methotrexate or taking folic acid supplements.

What data supports the effectiveness of the drug folic acid for arsenic poisoning?

Research shows that folic acid helps the body get rid of arsenic by aiding in its excretion, which can reduce arsenic toxicity. Additionally, studies in animals suggest that folic acid, especially when combined with vitamin B12, can protect against cell damage caused by arsenic. ^{1 2 3 4 5}

Is folic acid safe for humans?

Folic acid is generally considered safe for humans and has been shown to help reduce arsenic toxicity by aiding in its excretion from the body. It has protective effects against arsenic-induced damage in cells and animals, and it does not cause harm when used in studies for arsenic exposure. ^{1 2 3 5 6}

How does folic acid differ from other treatments for arsenic poisoning?

Folic acid is unique in treating arsenic poisoning because it helps the body excrete arsenic by enhancing methylation, a process that modifies arsenic to make it easier to eliminate. Unlike other treatments, folic acid specifically targets the methylation pathway, which is crucial for reducing arsenic toxicity. ^{1 2 3 5 7}

Research Team

Kevin G Dsouza, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 living in a specific area in Birmingham, Alabama with chronic arsenic exposure. Participants must be generally healthy without major health changes in the last month and not currently taking folic acid supplements or have conditions like megaloblastic anemia or malabsorptive syndromes.

Inclusion Criteria

Clinically stable with no significant changes in general health status in the past 4 weeks prior to screening as assessed by the investigator

Provide written informed consent

Resident of the superfund site

Exclusion Criteria

Pregnancy

I am currently using methotrexate.

Ongoing folic acid nutritional supplementation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either placebo or folic acid supplementation for 12 weeks

12 weeks

Baseline and end of treatment visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Folic Acid
• Placebo

Trial Overview The study is testing if taking folic acid can help reduce the effects of long-term arsenic poisoning compared to a placebo (a pill with no active ingredient). People will randomly receive either folic acid or placebo to see which works better.

Participant Groups

Group I: Folic Acid Experimental Treatment 1 Intervention

Folic acid 800 ug/day 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo daily 12 weeks

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Folic acid protects SWV/Fnn embryo fibroblasts against arsenic toxicity. [2019]

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

Supplementation with Folic Acid, but Not Creatine, Increases Plasma Betaine, Decreases Plasma Dimethylglycine, and Prevents a Decrease in Plasma Choline in Arsenic-Exposed Bangladeshi Adults. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. [2023]

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

Synergistic effect of folic acid and vitamin B12 in ameliorating arsenic-induced oxidative damage in pancreatic tissue of rat. [2013]

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

Antiapoptotic efficacy of folic acid and vitamin B₁₂ against arsenic-induced toxicity. [2018]

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

Embryonic protective role of folate in arsenic-induced cardiac malformations in rats. [2020]

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

Folic acid or combination of folic acid and vitamin B(12) prevents short-term arsenic trioxide-induced systemic and mitochondrial dysfunction and DNA damage. [2018]