Effects of Folic Acid Supplementation on Arsenic Lowering
Phase 2
- Conditions
- Arsenic PoisoningToxic Effect of Arsenic and Its Compounds
- Interventions
- Drug: folic acid supplementation
- Registration Number
- NCT02235948
- Lead Sponsor
- Wenzhou Medical University
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description folic acid folic acid supplementation folic acid supplementation placebo controlled
- Primary Outcome Measures
Name Time Method Change of urine arsenic metabolites between baseline and week 8 baseline, week 8
- Secondary Outcome Measures
Name Time Method