Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01749982
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2012-12-12
Brief Title:
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CABS
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 µgL 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 andor 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 andor betaine supplementation on arsenic methylation
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 andor betaine supplementation on arsenic methylation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None