Clinical trial NCT02235948: Effects of Folic Acid Supplementation on Arsenic Lowering
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Arsenic Poisoning
Toxic Effect of Arsenic and Its Compounds
Keywords: arsenic induced health problem
modifying effects
folic acid
oxidative damage
clinical trial
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: Outcome measure:

Changes of arsenic metabolites at baseline and week 8

Methods High-performance liquid chromatography (HPLC)

Eligibility criteria: 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;

Primary outcomes:
measure: Change of urine arsenic metabolites between baseline and week 8
timeFrame: baseline, week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wenzhou Medical University
name: Xiao Xiao, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.