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A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh


Phase 4
20 Years
65 Years
Not Enrolling
Both
Arsenic Metabolites Measured in Urine

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Trial Information

A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Urinary arsenic metabolites

Outcome Time Frame:

8 weeks after the start of the intervention

Safety Issue:

No

Principal Investigator

Megan N Hall, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

AAAJ1959

NCT ID:

NCT01749982

Start Date:

January 2013

Completion Date:

August 2013

Related Keywords:

  • Arsenic Metabolites Measured in Urine
  • arsenic
  • Bangladesh
  • choline
  • betaine
  • methylation

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