A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Condition: Arsenic Metabolites Measured in Urine
Intervention: Placebo; Choline bitartrate; Betaine; Choline bitartrate + Betaine
Intervention MeSH terms: Choline; Betaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: arsenic; Bangladesh; choline; betaine; methylation

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.
    

Eligibility 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