NCT01288950

Brief Summary

The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

February 1, 2011

Last Update Submit

August 20, 2012

Conditions

Tuberculosis

Keywords

BCG vaccineVitamin DCholecalciferolTuberculosis

Outcome Measures

Primary Outcomes (3)

  • Bacille-Calmette-Guerin (BCG) vaccine efficacy

    BCG vaccine efficacy will be assessed by measuring the host immune response against BCG at 2 months, 6 months and one year after BCG immunization. A whole blood assay will be used to measure multiple cytokines and mycobacterial growth suppression.

    2 months

  • Bacille-Calmette-Guerin (BCG) vaccine efficacy

    6 months

  • Bacille-Calmette-Guerin (BCG) vaccine efficacy

    1 year

Secondary Outcomes (2)

  • Effect of a single dose of 50,000 IU vitamin D3 on serum vitamin D levels

    2 months

  • Bacille-Calmette-Guerin (BCG) vaccine efficacy

    1 year

Study Arms (2)

Vitamin D3

EXPERIMENTAL
Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

NO INTERVENTION

Interventions

Vitamin D3 (cholecalciferol)DIETARY_SUPPLEMENT

A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination

Also known as: Carlson Ddrops liquid vitamin D3 2,000 IU per drop
Vitamin D3

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy mothers \> 18 years of age
  • Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine

You may not qualify if:

  • Recent maternal history of tuberculosis (within 1 year) or active tuberculosis
  • Known maternal human immuno-deficiency virus (HIV) infection
  • Maternal fever or chorio-amnionitis
  • Maternal use of vitamin D, steroids or immuno-regulatory medications
  • Household member with active tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tijuana General Hospital

Tijuana, Estado de Baja California, Mexico

Location

Related Publications (1)

  • Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

    PMID: 33305842DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Stephen Spector, MD

    University of California, San Diego

    STUDY CHAIR

  • Amaran Moodley, M.D

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 3, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

ME(1)