NCT03384862|Completed
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Sponsor study identifier
Secondary identifiers
interventional
239
1 country
1
Study Start
January 27, 2018
Actual (reported)Primary Completion
May 9, 2019
Actual (reported)Study Completion
May 9, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 9, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2017
Actual (reported)December 28, 2017
Actual (reported)January 27, 2018
Actual (reported)May 9, 2019
Actual (reported)May 9, 2019
Actual (reported)Change in arsenic methylation
Change in arsenic methylation patterns in blood and urine. The ability to methylate arsenic influences an individual's ability to excrete it in urine.
Up to 12 Weeks
Change in in blood arsenic
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
Up to 12 Weeks
Change in blood monomethyl arsenic
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.
Up to 12 Weeks
Change in WASI-II cognitive function test score
Up to 12 Weeks
5 μg vitamin B12 plus 400 μg folic acid
Placebo
5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
Columbia University Bangladesh
Dhaka, Bangladesh
Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.
Mary V Gamble, PhD
Columbia University
239 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2017
First Posted
December 28, 2017
Study Start
January 27, 2018
Actual (reported)Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias
400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
Contact the study team to confirm eligibility.
Primary Completion
May 9, 2019
Actual (reported)Study Completion
May 9, 2019
Actual (reported)Last Updated
February 16, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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