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.

Study Overview

• Status: Completed
• Conditions: Arsenic Exposure
• Intervention / Treatment: Dietary supplement: Vitamin B12; Dietary supplement: Folic Acid; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Columbia University Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Intervention Arm; 5 μg vitamin B12 plus 400 μg folic acid	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: Folic Acid; 400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
Placebo Comparator: Control Arm; Placebo	Dietary supplement: Placebo; Placebo pills, with same appearance as intervention pills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Mary V Gamble, PhD, Columbia University

Publications and helpful links

General Publications

• Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2018
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Arsenic exposure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: AAAQ9290; 2P42ES010349-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No