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Vitamin
Folic Acid for Arsenic Poisoning
N/A
Waitlist Available
Led By Kevin G Dsouza, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial tests if folic acid can help people exposed to arsenic in Alabama.
Who is the study for?
This trial is for adults over 18 living in a specific area in Birmingham, Alabama with chronic arsenic exposure. Participants must be generally healthy without major health changes in the last month and not currently taking folic acid supplements or have conditions like megaloblastic anemia or malabsorptive syndromes.
What is being tested?
The study is testing if taking folic acid can help reduce the effects of long-term arsenic poisoning compared to a placebo (a pill with no active ingredient). People will randomly receive either folic acid or placebo to see which works better.
What are the potential side effects?
Folic acid is usually safe but can sometimes cause mild side effects like nausea, loss of appetite, bloating, sleep disturbances, depression, and could rarely trigger allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measurement of urine and blood arsenic metabolites
Secondary study objectives
Pooled Cohort Probability Score
Respiratory Symptom Questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Folic AcidExperimental Treatment1 Intervention
Folic acid 800 ug/day 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo daily 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic Acid
2008
Completed Phase 4
~7540
Find a Location
Who is running the clinical trial?
National Institute of Environmental Health Sciences (NIEHS)NIH
291 Previous Clinical Trials
1,234,348 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,275 Total Patients Enrolled
Kevin G Dsouza, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using methotrexate.I have been diagnosed with megaloblastic anemia.I am 18 years old or older.I have a condition like celiac disease or inflammatory bowel disease that affects how my body absorbs nutrients.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Folic Acid
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.