Folic Acid for Arsenic Poisoning

KG
CT
Overseen ByCrystal T Stephens, MSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how folic acid might benefit people exposed to arsenic in Birmingham, Alabama. Researchers aim to determine if daily folic acid intake can improve health outcomes for those in high-arsenic areas. Participants will take either folic acid supplements or a placebo (a pill with no active ingredients) for 12 weeks. Eligible participants have lived in the affected area and maintain stable health without recent major changes. As an unphased trial, this study allows participants to contribute to important research that could lead to better health solutions for communities affected by arsenic exposure.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that folic acid is safe when taken in recommended amounts. One study found that taking 400 micrograms daily is not harmful. Other studies suggest that folic acid can help lower arsenic levels in the blood. Specifically, one study showed that people taking folic acid experienced a 13.62% drop in blood arsenic levels, compared to a 2.49% drop in those taking a placebo. These findings indicate that folic acid is generally well-tolerated and can be useful in reducing arsenic exposure.12345

Why do researchers think this study treatment might be promising for arsenic poisoning?

Unlike the standard treatments for arsenic poisoning, which often involve chelation therapy to bind and remove arsenic from the body, folic acid works differently by potentially enhancing the body's natural ability to repair damage caused by arsenic. Folic acid, a type of B vitamin, is being explored for its role in reducing arsenic toxicity by supporting methylation, a process that helps in detoxifying arsenic. Researchers are excited about folic acid because it could offer a more natural and less invasive approach, with the added benefit of being easily accessible and affordable.

What evidence suggests that folic acid might be an effective treatment for arsenic poisoning?

Research has shown that folic acid, which participants in this trial may receive, might help reduce arsenic's harmful effects by aiding its elimination from the body. Studies have found that folic acid intake can enhance the body's ability to process arsenic, leading to lower arsenic levels in blood and urine. Specifically, one study discovered that people taking folic acid experienced fewer symptoms related to long-term arsenic exposure compared to those who did not. These findings suggest that folic acid could help mitigate the impact of arsenic exposure.12567

Who Is on the Research Team?

KG

Kevin G Dsouza, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Folic AcidExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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+

Citations

Provision of folic acid for reducing arsenic toxicity in arsenic ...Folic acid may decrease arsenic toxicity by helping to remove arsenic from the body, thus lowering the amount of arsenic in the blood. This review assessed the ...
Influence of folic acid and vitamin B12 supplementation on ...This RCT confirms that FA + B12 supplementation increases arsenic methylation in children as reflected by decreased MMAs and increased DMAs in blood and urine.
Role of Folic Acid on Symptoms of Chronic Arsenic ToxicityIn this study, improvement of systemic disease symptom score was found to be significant in folic acid treated group compared to those taking arsenic safe water ...
The Folic Acid and Creatine Trial - ACS PublicationsHere, we investigate the metabolic profiles linked to arsenic exposure and metabolism based on a FA clinical trial.
Effects of Folic Acid Supplementation on Arsenic LoweringThe purpose of this study is to determine whether folic acid supplementation are effective on arsenic lowering in a chronic, low-level arsenic exposed ...
Folic Acid Safety, Interactions, and Health OutcomesFolic acid is safe and effective at the recommended amounts. Taking 400 mcg of folic acid per day has not been shown to cause harm.
Folic acid supplementation lowers blood arsenicTotal blood arsenic was reduced by 13.62% in the folic acid supplementation group and by 2.49% in the placebo group (P = 0.0199). Conclusions: Folic acid ...
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