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Clinical Trials/NCT03384862
NCT03384862
Completed
Not Applicable

Nutrition, Arsenic and Cognitive Function in Children

Columbia University1 site in 1 country239 target enrollmentJanuary 27, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arsenic Exposure
Sponsor
Columbia University
Enrollment
239
Locations
1
Primary Endpoint
Change in in blood arsenic
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.

Detailed Description

While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.

Registry
clinicaltrials.gov
Start Date
January 27, 2018
End Date
May 9, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Gamble

Associate Professor of Environmental Health Sciences

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort

Exclusion Criteria

  • children who are not attending school
  • children with known physical disability or known chronic illness

Outcomes

Primary Outcomes

Change in in blood arsenic

Time Frame: Up to 12 Weeks

Change in arsenic level in blood is to be measured in mg/L. This is an indicator of the body burden of arsenic and arsenic excretion

Change in arsenic methylation

Time Frame: Up to 12 Weeks

Change in arsenic methylation patterns in blood and urine. The ability to methylate arsenic influences an individual's ability to excrete it in urine.

Change in blood monomethyl arsenic

Time Frame: Up to 12 Weeks

Change in monomethyl arsenic level in blood is to be measured in units of ug/L. This is an indicator of the body burden of arsenic and arsenic methylation capacity.

Study Sites (1)

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