An interventional study of Vitamin B12 and Placebo in Arsenic Exposure, sponsored by Columbia University. Completed at 1 site in Bangladesh. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
5 μg vitamin B12 plus 400 μg folic acid
Dietary Supplement: Vitamin B12 · Dietary Supplement: Folic Acid
Placebo
Dietary Supplement: Placebo
5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
Placebo pills, with same appearance as intervention pills.
400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
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.
Time frame: 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
Time frame: 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.
Time frame: Up to 12 Weeks
Change in WASI-II cognitive function test score
An improvement in scores on a test of cognitive function after receiving dietary supplements represent potential partial mitigation of arsenic- and nutrition-related cognitive decrements. Wechsler Abbreviated Scale of Intelligence (WASI-II) is a screen of verbal, non-verbal, and general cognitive ability. Higher score indicates higher cognitive function. Scores on the WASI-II can range from below 70 (demonstrating cognitive deficiency) to above 200 (demonstrating incredible genius) - typical "normal" or "average" scores are between 90-100. Higher values indicate a better score in terms of cognitive outcome while lower values indicate a poorer score. An improvement on WASI-II test scores for these participants would be demonstrated in a higher score on this test after receiving the intervention.
Time frame: Up to 12 Weeks
Plan to share: Undecided
Ran from Jan 2018 to primary completion in May 2019, 15 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin B 12 · Folic Acid