Arsenic PoisoningPhase 2NCT02235948
Effects of Folic Acid Supplementation on Arsenic Lowering
A Phase 2 study testing folic acid supplementation in people with Arsenic Poisoning and Toxic Effect of Arsenic and Its Compounds, run by Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arsenic Poisoning, Toxic Effect of Arsenic and Its Compounds
- What is being tested?
- folic acid supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
About this study
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.
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.
Read the detailed description
Outcome measure:
Changes of arsenic metabolites at baseline and week 8
Methods High-performance liquid chromatography (HPLC)
- Being tested
- folic acid supplementation
- Keywords
- arsenic induced health problem, modifying effects, folic acid, oxidative damage, clinical trial
- Medical subject headings
- Arsenic Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid supplementationDrug
Also called placebo controlled
0.8mg folic acid/day
| Study group | Role | What they receive |
|---|---|---|
| folic acid | Experimental | folic acid supplementation placebo controlled Receives: Drug: folic acid supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urine arsenic metabolites between baseline and week 8
Measured: baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arsenic PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Xiao, Wenzhou Medical University
- Investigators
- Xiao Xiao, MD, PhD, Study director, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235948
- Sponsor's protocol ID
- Y211045
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34661903Wei 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.
PubMed 31666259Guo 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.
PubMed 26559255
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02235948
- Acronym / sponsor ID
- Y211045
- Keywords
- arsenic induced health problem, modifying effects, folic acid, oxidative damage, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| folic acid | Experimental | Drug: folic acid supplementationfolic acid supplementation placebo controlled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acid supplementationAlso: placebo controlled0.8mg folic acid/day | Drug | folic acid |
Primary outcome
Change of urine arsenic metabolites between baseline and week 8
Time frame: baseline, week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Derived from this study: PubMed 34661903Bae 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.
- Derived from this study: PubMed 31666259Wei 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.
- Derived from this study: PubMed 26559255Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Xiao, MD, PhD study director
Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing folic acid supplementation in people with Arsenic Poisoning and Toxic Effect of Arsenic and Its Compounds, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of urine arsenic metabolites between baseline and week 8 (time frame: baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235948, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.