- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235948
Effects of Folic Acid Supplementation on Arsenic Lowering
September 9, 2014 updated by: Xiao Xiao, Wenzhou Medical University
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.
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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Outcome measure:
Changes of arsenic metabolites at baseline and week 8
Methods High-performance liquid chromatography (HPLC)
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: folic acid
folic acid supplementation placebo controlled
|
0.8mg folic acid/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of urine arsenic metabolites between baseline and week 8
Time Frame: baseline, week 8
|
baseline, week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Xiao Xiao, MD, PhD, Wenzhou Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 28, 2014
First Submitted That Met QC Criteria
September 9, 2014
First Posted (Estimate)
September 10, 2014
Study Record Updates
Last Update Posted (Estimate)
September 10, 2014
Last Update Submitted That Met QC Criteria
September 9, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Y211045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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