Arsenic Poisoning, Toxic Effect of Arsenic and Its Compounds
Conditions
Keywords
arsenic induced health problem, modifying effects, folic acid, oxidative damage, clinical trial
Brief summary
The purpose of this study is to determine whether folic acid supplementation are effective on arsenic lowering in a chronic, low-level arsenic exposed population.
Detailed description
Outcome measure: Changes of arsenic metabolites at baseline and week 8 Methods High-performance liquid chromatography (HPLC)
Interventions
0.8mg folic acid/day
Sponsors
Wenzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women more than 18 years of age and chronically exposed to arsenic (arsenic concentration of the drinking water \>10ug/L); * Population who had no folic acid supplementation in the 2 weeks before the study; * Women of childbearing age agreed to use a reliable contraception method during the study; * Everyone volunteered to participate and signed informed consent.
Exclusion criteria
* Pregnant or breast-feeding women; * Allergic to folic acid; * Having clearly defined allergic history; * Reported long-term use of folic acid and other vitamins B; * Having obvious signs or laboratory abnormalities which could affect the efficacy of folic acid; * Unsuitable to participate in the study based on the judgment of the investigators; * Not agree to cancel the medications which may affect serum folate concentration during the study period; * Subjects who plan to become pregnant during the study or move out of the area within the study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of urine arsenic metabolites between baseline and week 8 | baseline, week 8 |
Outcome results
None listed