NCT03384862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2019

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

December 20, 2017

Last Update Submit

February 13, 2021

Conditions

Arsenic Exposure

Keywords

Arsenic exposure

Outcome Measures

Primary Outcomes (3)

  • 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

Other Outcomes (1)

  • Change in WASI-II cognitive function test score

    Up to 12 Weeks

Study Arms (2)

Nutritional Intervention Arm

EXPERIMENTAL

5 μg vitamin B12 plus 400 μg folic acid

Dietary Supplement: Vitamin B12Dietary Supplement: Folic Acid

Control Arm

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Vitamin B12DIETARY_SUPPLEMENT

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

Nutritional Intervention Arm
PlaceboDIETARY_SUPPLEMENT

Placebo pills, with same appearance as intervention pills.

Control Arm
Folic AcidDIETARY_SUPPLEMENT

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

Nutritional Intervention Arm

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort

You may not qualify if:

  • siblings
  • twins
  • children who are not attending school
  • children with known physical disability or known chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 34661903DERIVED

MeSH Terms

Interventions

Vitamin B 12Folic Acid

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPterinsPteridinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Mary V Gamble, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
All participants, field staff, and investigators will be blinded to the intervention status of participants.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Environmental Health Sciences

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

January 27, 2018

Primary Completion

May 9, 2019

Study Completion

May 9, 2019

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

BA(1)