Arsenic Metabolites Measured in Urine Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention