Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation

N/AEnrolling By InvitationNCT05656664

University of Alabama at Birmingham100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Arsenic and/or Arsenic Compound Adverse Reaction

Interventions

Folic AcidDIETARY_SUPPLEMENT

Folic acid supplementation to assess for increased arsenic metabolite excretion

PlaceboOTHER

Placebo group to assess arsenic metabolite excretion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UAB Lung Health Center

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Measurement of urine and blood arsenic metabolites

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.

Time frame: 12 weeks

Secondary Outcomes

Respiratory Symptom Questionnaire

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.

Time frame: 12 weeks

Pooled Cohort Probability Score

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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