Effects of Folic Acid Supplementation on Arsenic Lowering
NCT ID: NCT02235948
Last Updated: 2014-09-10
Study Results
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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UNKNOWN
PHASE2
450 participants
INTERVENTIONAL
2014-07-31
2016-12-31
Brief Summary
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Detailed Description
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Changes of arsenic metabolites at baseline and week 8
Methods High-performance liquid chromatography (HPLC)
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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folic acid
folic acid supplementation placebo controlled
folic acid supplementation
0.8mg folic acid/day
Interventions
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folic acid supplementation
0.8mg folic acid/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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Wenzhou Medical University
OTHER
Responsible Party
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Xiao Xiao
MD, PhD, professor
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.
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.
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.
Other Identifiers
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Y211045
Identifier Type: -
Identifier Source: org_study_id
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