Back to resultsEffects of Folic Acid Supplementation on Arsenic Lowering
Primary Purpose
Arsenic Poisoning, Toxic Effect of Arsenic and Its Compounds
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
folic acid supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Arsenic Poisoning focused on measuring arsenic induced health problem, modifying effects, folic acid, oxidative damage, clinical trial
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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
folic acid
Arm Description
folic acid supplementation placebo controlled
Outcomes
Primary Outcome Measures
Change of urine arsenic metabolites between baseline and week 8
Secondary Outcome Measures
Full Information
NCT ID
NCT02235948
First Posted
August 28, 2014
Last Updated
September 9, 2014
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02235948
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arsenic Poisoning, Toxic Effect of Arsenic and Its Compounds
Keywords
arsenic induced health problem, modifying effects, folic acid, oxidative damage, clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
folic acid
Arm Type
Experimental
Arm Description
folic acid supplementation placebo controlled
Intervention Type
Drug
Intervention Name(s)
folic acid supplementation
Other Intervention Name(s)
placebo controlled
Intervention Description
0.8mg folic acid/day
Primary Outcome Measure Information:
Title
Change of urine arsenic metabolites between baseline and week 8
Time Frame
baseline, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Xiao, MD, PhD
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
34661903
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.
Results Reference
derived
PubMed Identifier
31666259
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.
Results Reference
derived
PubMed Identifier
26559255
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.
Results Reference
derived
Learn more about this trial
Effects of Folic Acid Supplementation on Arsenic Lowering
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