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

NCT01749982 | Completed Phase 4 Results

• 1 other identifier: AAAJ1959
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

arsenic; Bangladesh; choline; betaine; methylation

Outcome Measures

Primary Outcomes (3)

• Change in Urinary % Monomethyl Arsenic

  From baseline to 8 weeks after the start of the intervention (week 8 - baseline)

• Change in Urinary % Inorganic Arsenic

  From baseline to 8 weeks after the start of the intervention (week 8 - baseline)

• Change in Urinary % Dimethyl Arsenic

  From baseline to 8 weeks after the start of the intervention (week 8 - baseline)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo tablets

Other: Placebo

Choline bitartrate

EXPERIMENTAL

Choline bitartrate 700 mg by mouth daily

Drug: Choline bitartrate

Betaine

EXPERIMENTAL

Betaine 1000 mg by mouth daily

Drug: Betaine

Choline bitartrate + Betaine

EXPERIMENTAL

Choline bitartrate 700 mg + Betaine 1000 mg daily

Drug: Choline bitartrate + Betaine

Interventions

Placebo OTHER

Placebo

Choline bitartrate DRUG

Choline bitartrate

Betaine DRUG

Betaine

Choline bitartrate + Betaine DRUG

Choline bitartrate + Betaine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-65

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Arsenic Research Project

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Choline; Betaine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Limitations and Caveats

This is a pilot study that is not powered to detect statistically significant effects. The results given here are descriptive.

Results Point of Contact

• Title: Megan N Hall
• Organization: Columbia University

mh2825@columbia.edu

212-305-3161

Study Officials

• Megan N Hall, ScD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

BA (1)