Skip to main content
OpenTrials
Completed

NCT Number: NCT03384862

Nutrition, Arsenic and Cognitive Function in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arsenic Exposure

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Bangladesh

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12

Dietary Supplement

5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.

Placebo

Dietary Supplement

Placebo pills, with same appearance as intervention pills.

Folic Acid

Dietary Supplement

400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.

Primary outcomes

  1. Change in arsenic methylation

    Time frame: 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.

  2. Change in in blood arsenic

    Time frame: 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

  3. Change in blood monomethyl arsenic

    Time frame: 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.

Other outcomes

  1. Change in WASI-II cognitive function test score

    Time frame: Up to 12 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2017
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.