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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
| P42ES027723 | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo daily 12 weeks |
|
| Folic Acid | Experimental | Folic acid 800 ug/day 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Dietary Supplement | Folic acid supplementation to assess for increased arsenic metabolite excretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin G Dsouza, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/ajcn/nqy148. |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Study procedures will consist of recruitment of 100 subjects, 50 each in the treatment (Folic Acid, 800 mcg) and placebo groups respectively. Folic Acid 800 mcg or placebo pill bottles will be provided to the participants with instructions to take one pill orally daily. Both the investigators and subjects will be blinded. Compliance will be measured via pill count.
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Study randomization will be performed by using a randomization scheme provided by the Investigational Drug Service (IDS). The randomization scheme will be held by IDS and concealed to investigators until the completion of the study.
| Placebo | Other | Placebo group to assess arsenic metabolite excretion |
|
| 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. | 12 weeks |
| D006571 | Heterocyclic Compounds |