Nutrition, Arsenic and Cognitive Function in Children

NCT ID: NCT03384862

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-27

Study Completion Date

2019-05-09

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.

Conditions

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Arsenic Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
All participants, field staff, and investigators will be blinded to the intervention status of participants.

Study Groups

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Nutritional Intervention Arm

5 μg vitamin B12 plus 400 μg folic acid

Group Type EXPERIMENTAL

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

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

Folic Acid

Intervention Type DIETARY_SUPPLEMENT

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

Control Arm

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo pills, with same appearance as intervention pills.

Interventions

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Vitamin B12

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pills, with same appearance as intervention pills.

Intervention Type DIETARY_SUPPLEMENT

Folic Acid

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Mary Gamble

Associate Professor of Environmental Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary V Gamble, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Bangladesh

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 34661903 (View on PubMed)

Other Identifiers

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2P42ES010349-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAQ9290

Identifier Type: -

Identifier Source: org_study_id

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