MedTrace Logo

Nutrition, Arsenic and Cognitive Function in Children

NCT03384862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-02-16

No results posted yet for this study

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.

Conditions

  • Arsenic Exposure

Interventions

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

Placebo

Placebo pills, with same appearance as intervention pills.

DIETARY_SUPPLEMENT

Folic Acid

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

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Mary V Gamble, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-27
Primary Completion
2019-05-09
Completion
2019-05-09

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384862 on ClinicalTrials.gov