Nutrition, Arsenic and Cognitive Function in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutrition, Arsenic and Cognitive Function in Children

Conditions
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Arsenic Exposure

Intervention / Treatment
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* Dietary Supplement: Vitamin B12
* Dietary Supplement: Placebo
* Dietary Supplement: Folic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arsenic exposure