[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05656664":3,"trial-entities:NCT05656664":91,"trial-summary:NCT05656664":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":67,"locations":70,"central_contacts":80,"overall_officials":81,"references":85,"see_also_links":90},"NCT05656664","300010144","Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation","Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health","ENROLLING_BY_INVITATION","2026-12-31","2026-03","2026-04-30","2023-09-14","University of Alabama at Birmingham","OTHER",true,"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",[19],"Arsenic and\u002For Arsenic Compound Adverse Reaction",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},100,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","Folic Acid","Folic acid supplementation to assess for increased arsenic metabolite excretion",[31],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Placebo","Placebo group to assess arsenic metabolite excretion",[35],[39],{"measure":40,"description":41,"timeFrame":42},"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.\n\nWe 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.","12 weeks",[44,47],{"measure":45,"description":46,"timeFrame":42},"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\u002For 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.",{"measure":48,"description":49,"timeFrame":42},"Pooled Cohort Probability Score","The pooled cohort probability score has been used to detect subclinical airway obstruction. Age, sex, race and\u002For ethnicity, body mass index, smoking status, and smoking pack-years will be obtained and the score will be computed at baseline.","ALL","18 Years","89 Years",{"inclusion":54,"exclusion":59,"raw_text":66},[55,56,57,58],"≥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",[60,61,62,63,64,65],"Pregnancy","Ongoing folic acid nutritional supplementation","Methotrexate use","Megaloblastic anemia","Alcoholic liver disease","Malabsorptive syndromes - celiac disease, inflammatory bowel disease","Inclusion Criteria:\n\n* ≥18 years of age\n* Resident of the superfund site\n* Clinically stable with no significant changes in general health status in the past 4 weeks prior to screening as assessed by the investigator\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Ongoing folic acid nutritional supplementation\n* Methotrexate use\n* Megaloblastic anemia\n* Alcoholic liver disease\n* Malabsorptive syndromes - celiac disease, inflammatory bowel disease",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"UAB Lung Health Center","Birmingham","Alabama","35205","United States",{"lat":78,"lon":79},33.52066,-86.80249,[],[82],{"name":83,"affiliation":13,"role":84},"Kevin G Dsouza, MD","PRINCIPAL_INVESTIGATOR",[86],{"pmid":87,"type":88,"citation":89},"30590411","RESULT","Bozack AK, Hall MN, Liu X, Ilievski V, Lomax-Luu AM, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. Folic acid supplementation enhances arsenic methylation: results from a folic acid and creatine supplementation randomized controlled trial in Bangladesh. Am J Clin Nutr. 2019 Feb 1;109(2):380-391. doi: 10.1093\u002Fajcn\u002Fnqy148.",[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Arsenic Compound Adverse Reaction",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":97},false,null]