Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Folic Acid, Placebo.
- Who it may be relevant to
- Registry conditions: Arsenic and/or Arsenic Compound Adverse Reaction. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health
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.
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
Interventions
- Dietary supplement Folic Acid
Folic acid supplementation to assess for increased arsenic metabolite excretion - Other Placebo
Placebo group to assess arsenic metabolite excretion
Primary outcome measures
- Measurement of urine and blood arsenic metabolites [Time frame: 12 weeks]
Secondary outcome measures (2)
- Respiratory Symptom Questionnaire [Time frame: 12 weeks]
- Pooled Cohort Probability Score [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UAB Lung Health Center — Birmingham
Publications
- 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. PMID 30590411
Identifiers
NCT: NCT05656664 · 300010144