Clinical trial NCT01749982: A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Official title: A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arsenic Metabolites Measured in Urine
Keywords: arsenic
Bangladesh
choline
betaine
methylation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Urinary % Monomethyl Arsenic
timeFrame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
measure: Change in Urinary % Inorganic Arsenic
timeFrame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
measure: Change in Urinary % Dimethyl Arsenic
timeFrame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Columbia University Arsenic Research Project
Study officials:
affiliation: Columbia University
name: Megan N Hall, ScD
role: PRINCIPAL_INVESTIGATOR
References: