UAB Lung Health Center
Birmingham, Alabama, 35205, United States
NCT Number: NCT05656664
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.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35205, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Folic acid supplementation to assess for increased arsenic metabolite excretion
Placebo group to assess arsenic metabolite excretion
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.
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.
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.
University of Alabama at Birmingham
Other
Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health
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.