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

Columbia University

Status and phase: Completed; Phase 4

Conditions: Arsenic Metabolites Measured in Urine

Treatments: Drug: Choline bitartrate; Drug: Choline bitartrate + Betaine; Other: Placebo; Drug: Betaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01749982

AAAJ1959

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Other: Placebo

Choline bitartrate

Experimental group

Description:

Choline bitartrate 700 mg by mouth daily

Treatment:

Drug: Choline bitartrate

Betaine

Experimental group

Description:

Betaine 1000 mg by mouth daily

Treatment:

Drug: Betaine

Choline bitartrate + Betaine

Experimental group

Description:

Choline bitartrate 700 mg + Betaine 1000 mg daily

Treatment:

Drug: Choline bitartrate + Betaine