Effects of Folic Acid Supplementation on Arsenic Lowering

NCT ID: NCT02235948

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Outcome measure:

Changes of arsenic metabolites at baseline and week 8

Methods High-performance liquid chromatography (HPLC)

Conditions

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Arsenic Poisoning Toxic Effect of Arsenic and Its Compounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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folic acid

folic acid supplementation placebo controlled

Group Type EXPERIMENTAL

folic acid supplementation

Intervention Type DRUG

0.8mg folic acid/day

Interventions

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folic acid supplementation

0.8mg folic acid/day

Intervention Type DRUG

Other Intervention Names

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placebo controlled

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiao Xiao

MD, PhD, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao Xiao, MD, PhD

Role: STUDY_DIRECTOR

Wenzhou Medical University

References

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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.

Reference Type DERIVED
PMID: 34661903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31666259 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26559255 (View on PubMed)

Other Identifiers

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Y211045

Identifier Type: -

Identifier Source: org_study_id

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