Arsenic Metabolites Measured in UrinePhase 4CABSNCT01749982
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
A Phase 4 study testing Choline bitartrate, Betaine and Choline bitartrate + Betaine in people with Arsenic Metabolites Measured in Urine, run by Columbia University at 1 site in Bangladesh.
Trial summary
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Arsenic Metabolites Measured in Urine
- What is being tested?
- Choline bitartrate, Betaine and Choline bitartrate + Betaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65
- Absence of all exclusion criteria
Who cannot join
- women who are currently pregnant at the time of recruitment and/or plan to become pregnant within 2 months
- individuals taking nutritional supplements at the time of recruitment
- individuals who have taken nutritional supplements within the last 3 months
- participants enrolled in any other clinical trial
- women who are currently breastfeeding
- individuals known to have coronary heart disease, cerebrovascular disease, hypertension, renal disease, chronic obstructive pulmonary disease, asthma, cancer, or liver disease
- participants with protein or glucose in their urine sample (dipstick test)
- individuals whose drinking water history is complete for < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.
The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.
- Conditions
- Arsenic Metabolites Measured in Urine
- Being tested
- Placebo, Choline bitartrate, Betaine, Choline bitartrate + Betaine
- Keywords
- arsenic, Bangladesh, choline, betaine, methylation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Choline bitartrateDrug
BetaineDrug
Choline bitartrate + BetaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets Receives: Other: Placebo |
| Choline bitartrate | Experimental | Choline bitartrate 700 mg by mouth daily Receives: Drug: Choline bitartrate |
| Betaine | Experimental | Betaine 1000 mg by mouth daily Receives: Drug: Betaine |
| Choline bitartrate + Betaine | Experimental | Choline bitartrate 700 mg + Betaine 1000 mg daily Receives: Drug: Choline bitartrate + Betaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary % Monomethyl Arsenic
Measured: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Inorganic Arsenic
Measured: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Dimethyl Arsenic
Measured: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arsenic Metabolites Measured in UrineStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Hall, Columbia University
- Investigators
- Megan N Hall, ScD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749982
- Sponsor's protocol ID
- AAAJ1959
- Acronym
- CABS
- Status last verified
- Aug 2014
- First submitted
- 12 Dec 2012
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
- ClinicalTrials.gov ID
- NCT01749982
- Acronym / sponsor ID
- CABS / AAAJ1959
- Conditions
- Arsenic Metabolites Measured in Urine
- Keywords
- arsenic, Bangladesh, choline, betaine, methylation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.
The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablets |
| Choline bitartrate | Experimental | Drug: Choline bitartrateCholine bitartrate 700 mg by mouth daily |
| Betaine | Experimental | Drug: BetaineBetaine 1000 mg by mouth daily |
| Choline bitartrate + Betaine | Experimental | Drug: Choline bitartrate + BetaineCholine bitartrate 700 mg + Betaine 1000 mg daily |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-65
- Absence of all exclusion criteria
Key exclusion criteria (8 listed)
- women who are currently pregnant at the time of recruitment and/or plan to become pregnant within 2 months
- individuals taking nutritional supplements at the time of recruitment
- individuals who have taken nutritional supplements within the last 3 months
- participants enrolled in any other clinical trial
- women who are currently breastfeeding
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 |
|---|---|---|
| Placebo | Other | Placebo |
| Choline bitartrate | Drug | Choline bitartrate |
| Betaine | Drug | Betaine |
| Choline bitartrate + Betaine | Drug | Choline bitartrate + Betaine |
Primary outcome
Change in Urinary % Monomethyl Arsenic
Time frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Inorganic Arsenic
Time frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Dimethyl Arsenic
Time frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Megan N Hall, ScD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Choline bitartrate, Betaine and Choline bitartrate + Betaine in people with Arsenic Metabolites Measured in Urine, run by Columbia University at 1 site in Bangladesh.
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 2 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: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Urinary % Monomethyl Arsenic (time frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2014.