Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Arsenic and/or Arsenic Compound Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study procedures will consist of recruitment of 100 subjects, 50 each in the treatment (Folic Acid, 800 mcg) and placebo groups respectively. Folic Acid 800 mcg or placebo pill bottles will be provided to the participants with instructions to take one pill orally daily. Both the investigators and subjects will be blinded. Compliance will be measured via pill count.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study randomization will be performed by using a randomization scheme provided by the Investigational Drug Service (IDS). The randomization scheme will be held by IDS and concealed to investigators until the completion of the study.

Study Groups

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Placebo

Placebo daily 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo group to assess arsenic metabolite excretion

Folic Acid

Folic acid 800 ug/day 12 weeks

Group Type EXPERIMENTAL

Folic Acid

Intervention Type DIETARY_SUPPLEMENT

Folic acid supplementation to assess for increased arsenic metabolite excretion

Interventions

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Folic Acid

Folic acid supplementation to assess for increased arsenic metabolite excretion

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo group to assess arsenic metabolite excretion

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes