Effects of Folic Acid Supplementation on Arsenic Lowering

September 9, 2014 updated by: Xiao Xiao, Wenzhou Medical University

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.

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.

Study Overview

Detailed Description

Outcome measure:

Changes of arsenic metabolites at baseline and week 8

Methods High-performance liquid chromatography (HPLC)

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: folic acid
folic acid supplementation placebo controlled
0.8mg folic acid/day
Other Names:
  • placebo controlled

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Xiao Xiao, MD, PhD, Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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