Nutrition, Arsenic and Cognitive Function in Children

Not Applicable

Completed

• Conditions: Arsenic Exposure
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid

• Registration Number: NCT03384862
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-01-27
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-13
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Intervention Arm	Folic Acid	5 μg vitamin B12 plus 400 μg folic acid
Control Arm	Placebo	Placebo
Nutritional Intervention Arm	Vitamin B12	5 μg vitamin B12 plus 400 μg folic acid

Primary Outcome Measures

Name	Time	Method
Change in in blood arsenic	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	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	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.

Trial Locations

Locations (1)

Columbia University Bangladesh; 🇧🇩 Dhaka, Bangladesh