Effects of Folic Acid Supplementation on Arsenic Lowering

NCT02235948 | Unknown Phase 2 DMC

• 1 other identifier: Y211045
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arsenic Poisoning; Toxic Effect of Arsenic and Its Compounds

Keywords

arsenic induced health problem; modifying effects; folic acid; oxidative damage; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change of urine arsenic metabolites between baseline and week 8

  baseline, week 8

Study Arms (1)

folic acid

EXPERIMENTAL

folic acid supplementation placebo controlled

Drug: folic acid supplementation

Interventions

folic acid supplementation DRUG

0.8mg folic acid/day

Also known as: placebo controlled

folic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Wenzhou Medical University: lead

Related Publications (3)

• Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.

  PMID: 34661903 DERIVED

• Wei Y, Jia C, Lan Y, Hou X, Zuo J, Li J, Wang T, Mao G. The association of tryptophan and phenylalanine are associated with arsenic-induced skin lesions in a Chinese population chronically exposed to arsenic via drinking water: a case-control study. BMJ Open. 2019 Oct 30;9(10):e025336. doi: 10.1136/bmjopen-2018-025336.

  PMID: 31666259 DERIVED

• Guo X, Cui H, Zhang H, Guan X, Zhang Z, Jia C, Wu J, Yang H, Qiu W, Zhang C, Yang Z, Chen Z, Mao G. Protective Effect of Folic Acid on Oxidative DNA Damage: A Randomized, Double-Blind, and Placebo Controlled Clinical Trial. Medicine (Baltimore). 2015 Nov;94(45):e1872. doi: 10.1097/MD.0000000000001872.

  PMID: 26559255 DERIVED

MeSH Terms

Conditions

Arsenic Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Xiao Xiao, MD, PhD

  Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 10, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 10, 2014

Record last verified: 2014-09