Arsenic Metabolites Measured in Urine Clinical Trial
— CABSOfficial 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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2014 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | Columbia University Arsenic Research Project | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| Columbia University |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Urinary % Monomethyl Arsenic | From baseline to 8 weeks after the start of the intervention (week 8 - baseline) | No | |
| Primary | Change in Urinary % Inorganic Arsenic | From baseline to 8 weeks after the start of the intervention (week 8 - baseline) | No | |
| Primary | Change in Urinary % Dimethyl Arsenic | From baseline to 8 weeks after the start of the intervention (week 8 - baseline) | No |