SNPMiner Trials (Home Page)
Report for Clinical Trial NCT01288950
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants
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.
NCT01288950 Tuberculosis MeSH:Tuberculosis
1 Interventions
Name: Vitamin D3 (cholecalciferol)
Primary Outcomes
Description: 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.
Measure: Bacille-Calmette-Guerin (BCG) vaccine efficacy Time: 2 monthsMeasure: Bacille-Calmette-Guerin (BCG) vaccine efficacy Time: 6 months
Measure: Bacille-Calmette-Guerin (BCG) vaccine efficacy Time: 1 year
Secondary Outcomes
Description: Serum 25 hydroxy (OH) vitamin D levels will be measured prior to vitamin D supplementation and at 2 months, 6 months and one year after BCG immunization. The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.
Measure: Effect of a single dose of 50,000 IU vitamin D3 on serum vitamin D levels Time: 2 monthsDescription: The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.
Measure: Bacille-Calmette-Guerin (BCG) vaccine efficacy Time: 1 yearPurpose: Prevention
Allocation: Randomized
Parallel Assignment
There are 4 SNPs
SNPs
1 rs10741657
The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.. Bacille-Calmette-Guerin (BCG) vaccine efficacy.
The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.. Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Tuberculosis Tuberculosis In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease.
2 rs12785878
The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.. Bacille-Calmette-Guerin (BCG) vaccine efficacy.
The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.. Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Tuberculosis Tuberculosis In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease.
3 rs1544410
The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.. Bacille-Calmette-Guerin (BCG) vaccine efficacy.
The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.. Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Tuberculosis Tuberculosis In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease.
4 rs2228570
The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.. Bacille-Calmette-Guerin (BCG) vaccine efficacy.
The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.. Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Inclusion Criteria: - Healthy mothers > 18 years of age - Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine Exclusion Criteria: - 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 Tuberculosis Tuberculosis In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease.