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Nutrition, Arsenic and Cognitive Function in Children

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Columbia University

Status

Completed

Conditions

Arsenic Exposure

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03384862
AAAQ9290
2P42ES010349-16 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

239 patients

Sex

All

Ages

8 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

239 participants in 2 patient groups, including a placebo group

Nutritional Intervention Arm
Experimental group
Description:
5 μg vitamin B12 plus 400 μg folic acid
Treatment:
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Control Arm
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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