Arsenic Exposure
Conditions
Keywords
Arsenic exposure
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.
Interventions
DIETARY_SUPPLEMENTVitamin B12
5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
DIETARY_SUPPLEMENTPlacebo
Placebo pills, with same appearance as intervention pills.
DIETARY_SUPPLEMENTFolic Acid
400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All participants, field staff, and investigators will be blinded to the intervention status of participants.
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in WASI-II cognitive function test score | 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. |
Countries
Bangladesh
Outcome results
None listed