Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

Not Applicable

• Conditions: Arsenic and/or Arsenic Compound Adverse Reaction
• Interventions: Dietary Supplement: Folic Acid; Other: Placebo

• Registration Number: NCT05656664
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-19
• Study Start: 2023-09-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folic Acid	Folic Acid	Folic acid 800 ug/day 12 weeks
Placebo	Placebo	Placebo daily 12 weeks

Primary Outcome Measures

Name	Time	Method
Measurement of urine and blood arsenic metabolites	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 Outcome Measures

Name	Time	Method
Pooled Cohort Probability Score	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.
Respiratory Symptom Questionnaire	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.

Trial Locations

Locations (1)

UAB Lung Health Center; 🇺🇸 Birmingham, Alabama, United States