NCT03384862

Nutrition, Arsenic and Cognitive Function in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arsenic Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin B12	5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
DIETARY_SUPPLEMENT	Placebo	Placebo pills, with same appearance as intervention pills.
DIETARY_SUPPLEMENT	Folic Acid	400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.

Timeline

• Start date: 2018-01-27
• Primary completion: 2019-05-09
• Completion: 2019-05-09
• First posted: 2017-12-28
• Last updated: 2021-02-16

Locations

1 site across 1 country: Bangladesh