Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

The University of Alabama at Birmingham

Status: Invitation-only

Conditions: Arsenic and/or Arsenic Compound Adverse Reaction

Treatments: Dietary Supplement: Folic Acid; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05656664

300010144

Details and patient eligibility

About

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.

Full description

Folic acid supplementation effects urinary arsenic excretion. In this project investigators propose to investigate if oral folic acid dietary supplementation can increase urinary arsenic metabolite excretion

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Resident of the superfund site
• 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

Exclusion criteria

• Pregnancy
• Ongoing folic acid nutritional supplementation
• Methotrexate use
• Megaloblastic anemia
• Alcoholic liver disease
• Malabsorptive syndromes - celiac disease, inflammatory bowel disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo daily 12 weeks

Treatment:

Other: Placebo

Folic Acid

Experimental group

Description:

Folic acid 800 ug/day 12 weeks

Treatment:

Dietary Supplement: Folic Acid