Effects of Folic Acid Supplementation on Arsenic Lowering

Wenzhou Medical University

Status and phase

Unknown

Phase 2

Conditions

Toxic Effect of Arsenic and Its Compounds

Arsenic Poisoning

Treatments

Drug: folic acid supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT02235948

Y211045

Details and patient eligibility

About

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.

Full description

Outcome measure:

Changes of arsenic metabolites at baseline and week 8

Methods High-performance liquid chromatography (HPLC)

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;