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

August 14, 2014 updated by: Megan Hall, Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Columbia University Arsenic Research Project

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Urinary % Monomethyl Arsenic
Time Frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
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)
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)
From baseline to 8 weeks after the start of the intervention (week 8 - baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Megan N Hall, ScD, Columbia University

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

December 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAJ1959

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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