Nutrition, Arsenic and Cognitive Function in Children

Arsenic Exposure Clinical Trial

Official title:

Nutrition, Arsenic and Cognitive Function in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384862
• Other study ID #: AAAQ9290
• Secondary ID: 2P42ES010349-16
• Status: Completed
• Phase: N/A
• Start date: January 27, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: February 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arsenic Exposure

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Columbia University Bangladesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 12 Weeks
Primary	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
Primary	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
Primary	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