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A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh (CABS)

This study is not yet open for participant recruitment.
Verified December 2012 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Megan Hall, Columbia University
ClinicalTrials.gov Identifier:
NCT01749982
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Arsenic Metabolites Measured in Urine
 Other: Placebo
Drug: Choline bitartrate
Drug: Betaine
Drug: Choline bitartrate + Betaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh

Resource links provided by NLM:

MedlinePlus related topics: Arsenic
U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Urinary arsenic metabolites [ Time Frame: 8 weeks after the start of the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablets
 Other: Placebo
Experimental: Choline bitartrate
Choline bitartrate 700 mg by mouth daily
 Drug: Choline bitartrate
Experimental: Betaine
Betaine 1000 mg by mouth daily
 Drug: Betaine
Experimental: Choline bitartrate + Betaine
Choline bitartrate 700 mg + Betaine 1000 mg daily
 Drug: Choline bitartrate + Betaine

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20-65
  • Absence of all exclusion criteria

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749982

Contacts
Contact: Megan N Hall, ScD 212-305-3161 mh2825@columbia.edu

Locations
Bangladesh
Columbia University Arsenic Research Project Not yet recruiting
Dhaka, Bangladesh
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Megan N Hall, ScD Columbia University
  More Information

No publications provided

Responsible Party: Megan Hall, Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01749982     History of Changes
Other Study ID Numbers: AAAJ1959
Study First Received: December 12, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration
Bangladesh: Bangladesh Medical Research Council

Keywords provided by Columbia University:
arsenic
Bangladesh
choline
betaine
methylation

Additional relevant MeSH terms:
Betaine
Choline
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Lipotropic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013