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Enrolling by Invitation

NCT Number: NCT05656664

Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

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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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Lung Health Center

Birmingham, Alabama, 35205, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Dietary Supplement

Folic acid supplementation to assess for increased arsenic metabolite excretion

Placebo

Other

Placebo group to assess arsenic metabolite excretion

Primary outcomes

  1. Measurement of urine and blood arsenic metabolites

    Time frame: 12 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.

Secondary outcomes

  1. Respiratory Symptom Questionnaire

    Time frame: 12 weeks

    The Respiratory Symptom Questionnaire (RSQ) is an instrument that assesses the frequency of respiratory symptoms and their impact on patients' activity over the previous four weeks, without requiring a specific diagnostic label of asthma or chronic obstructive pulmonary disease (COPD). The four questions assess the frequency of respiratory symptoms (shortness of breath, wheezing, coughing, and/or chest tightness) during the day and, in response to these respiratory symptoms, frequency of rescue inhaler use, activity limitations and frequency of night-time awakening. We will administer the RSQ to participants at the baseline screening. Maximum value 16, minimum value 4, higher scores represent increased symptom burden.

  2. Pooled Cohort Probability Score

    Time frame: 12 weeks

    The pooled cohort probability score has been used to detect subclinical airway obstruction. Age, sex, race and/or ethnicity, body mass index, smoking status, and smoking pack-years will be obtained and the score will be computed at baseline.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • P42ES027723

Registry information

Official study title

Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.