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NCT05656664

Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

Enrolling by Invitation
NAAges 18–89InterventionalPrevention
University of Alabama at Birmingham
~100 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Folic AcidPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurement of urine and blood arsenic metabolites
Measured over 12 weeks

Conditions

Arsenic and/or Arsenic Compound Adverse Reaction

Explore related trials

Arsenic Compound Adverse Reaction

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Kevin G Dsouza, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

≥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

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

What this trial measures

  • Measurement of urine and blood arsenic metabolites12 weeks

    Inorganic As (InAs) within humans undergoes a stepwise biotransformation reaction in which it is methylated to monomethyl-arsonic acid (MMAsIII), and dimethylarsinic acid (DMAsV) facilitating urinary excretion. This occurs via arsenic methyltransferase (AS3MT) using a methyl donor S-adenosylmethionine (SAM). In this pathway the one-carbon unit carried by 5-methyl-tetrahydrofolate (5-MTHF) is transferred to homocysteine to form methionine, which is activated to SAM. Complete methylation to DMAsV is critical as higher proportion of MMAs(III+V) are associated with skin lesions, peripheral vascular disease, atherosclerosis, and cancers. We will measure levels of InAs, total DMA and MMA in the urine and blood of the study subjects at baseline and 12 weeks. Outcomes will be reported in percentage (%) of InAs, DMA and MMA in blood and urine.