Effects of Folic Acid Supplementation on Arsenic Lowering

Overview

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 Title of Study: “Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2015

Detailed Description

Outcome measure: Changes of arsenic metabolites at baseline and week 8 Methods High-performance liquid chromatography (HPLC)

Interventions

  • Drug: folic acid supplementation
    • 0.8mg folic acid/day

Arms, Groups and Cohorts

  • Experimental: folic acid
    • folic acid supplementation placebo controlled

Clinical Trial Outcome Measures

Primary Measures

  • Change of urine arsenic metabolites between baseline and week 8
    • Time Frame: baseline, week 8

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wenzhou Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiao Xiao, MD, PhD, professor – Wenzhou Medical University
  • Overall Official(s)
    • Xiao Xiao, MD, PhD, Study Director, Wenzhou Medical University

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