Status:
UNKNOWN
Effects of Folic Acid Supplementation on Arsenic Lowering
Lead Sponsor:
Wenzhou Medical University
Conditions:
Arsenic Poisoning
Toxic Effect of Arsenic and Its Compounds
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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)
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02235948
Start Date
July 1 2014
End Date
December 1 2016
Last Update
September 10 2014
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