Effects of Folic Acid Supplementation on Arsenic Lowering

Arsenic Poisoning Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02235948
• Other study ID #: Y211045
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 28, 2014
• Last updated: September 9, 2014
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Outcome measure:

Changes of arsenic metabolites at baseline and week 8

Methods High-performance liquid chromatography (HPLC)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arsenic Poisoning
• Toxic Effect of Arsenic and Its Compounds

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of urine arsenic metabolites between baseline and week 8		baseline, week 8	Yes