Cholecalciferol and Flu Vaccine in Treating Healthy Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01561989
First received: March 16, 2012
Last updated: August 14, 2014
Last verified: August 2014

March 16, 2012
August 14, 2014
October 2011
July 2013   (final data collection date for primary outcome measure)
  • Effect of 25-hydroxy vitamin D3 levels on immunologic response (antibody responses) to injectable seasonal (2011-2012) trivalent influenza vaccine (Observational component) [ Time Frame: At 4 weeks post-vaccination ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.
  • Effect of cholecalciferol supplementation on immunologic response (antibody response) to injectable seasonal (2012-2013) trivalent influenza vaccine (Intervention component) [ Time Frame: Up to 24 weeks post-vaccination ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population. Will be estimated with confidence intervals at each time point. Tested by Wald Chi-square test, and the odds ratio (with confidence intervals) will be reported.
  • Effect of 25-hydroxy vitamin D3 levels on immunologic response (antibody responses) to injectable seasonal (2011-2012) trivalent influenza vaccine (Observational component) [ Time Frame: Baseline (pre-vaccination) and post-vaccination at week 4 ] [ Designated as safety issue: No ]
  • Effect of cholecalciferol supplementation on immunologic response (antibody response) to injectable seasonal (2012-2013) trivalent influenza vaccine (Intervention component) [ Time Frame: Baseline (pre-vaccination) and post-vaccination at weeks 16, 20, and 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01561989 on ClinicalTrials.gov Archive Site
  • Occurrences of flu-like illness (Observational component) [ Time Frame: Up to April 1, 2012 ] [ Designated as safety issue: No ]
  • Relationship between 25-hydroxy vitamin D3 levels at time of vaccination and immunologic responses following administration of the injected seasonal (2012-2013) trivalent influenza vaccine (Intervention component) [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
  • Occurrences of flu-like illnesses (Intervention component) [ Time Frame: Up to April 1, 2013 ] [ Designated as safety issue: No ]
  • Association between SNPs and polymorphisms in the DNA sequence of vitamin-D3 metabolizing enzymes, measures of vitamin-D3 metabolism (24,25 OH vitamin D3) and response to seasonal (2012-201) trivalent influenza vaccine (Intervention component) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Occurrences of flu-like illness (Observational component) [ Time Frame: Over 4 months ] [ Designated as safety issue: No ]
  • Relationship between 25-hydroxy vitamin D3 levels at time of vaccination and immunologic responses following administration of the injected seasonal (2012-2013) trivalent influenza vaccine (Intervention component) [ Time Frame: Week 20 and 24 ] [ Designated as safety issue: No ]
  • Occurrences of flu-like illnesses (Intervention component) [ Time Frame: Over 4 months ] [ Designated as safety issue: No ]
  • Associations between measures of cholecalciferol metabolism, SNPs and polymorphisms in the DNA sequence of cholecalciferol metabolizing enzymes, expression of mircoRNAs, and response to seasonal (2012-2013) influenza vaccine (Intervention component) [ Time Frame: Baseline (pre-vaccination) and post-vaccination at weeks 16, 20, and 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cholecalciferol and Flu Vaccine in Treating Healthy Participants
Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status

This randomized clinical trial studies cholecalciferol and flu vaccine in treating healthy participants. Cholecalciferol may increase the immunologic response of flu vaccine in healthy participants. Flu vaccine may help the body build an immune response and help prevent flu

PRIMARY OBJECTIVES:

I. To examine the effect of 25-hydroxy vitamin D3 levels on the immunologic response (antibody responses week 4 [4 weeks (+/- 7 days)] post-vaccination) to the injectable seasonal (2011-2012) trivalent influenza vaccine among Roswell Park Cancer Institute (RPCI) employees. (Observational component) II. To examine the effect of vitamin D3 (cholecalciferol) supplementation on the immunologic response (antibody response Week 16 [4 weeks (+/- 7 days)] post-vaccination) to the injectable seasonal (2012-2013) trivalent influenza vaccine among RPCI employees. (Intervention component)

SECONDARY OBJECTIVES:

I. To track occurrences of flu-like illness in the study population from November 1, 2011 through April 1, 2012, using a standardized epidemiologic questionnaire. (Observational component) II. To determine the relationship between 25-hydroxy vitamin D3 levels at time of vaccination and its immunologic responses Week 20 (8 weeks [+/- 7 days]) and Week 24 (12 weeks [+/- 7 days]) following administration of the injected seasonal (2012-2013) trivalent influenza vaccine. (Intervention component) III. To track occurrences of flu-like illnesses in the study population from November 2012 through April 2013, using a standardized epidemiologic questionnaire. (Intervention component) IV. To evaluate the association between single-nucleotide polymorphisms (SNPs) and polymorphisms in the deoxyribonucleic acid (DNA) sequence of vitamin-D3 metabolizing enzymes, measures of vitamin-D3 metabolism (24,25 hydroxy [OH] vitamin D3) and response to seasonal (2012-201) trivalent influenza vaccine. (Intervention component)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive low-dose cholecalciferol orally (PO) once daily (QD) for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine intramuscularly (IM).

ARM II: Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.

After completion of study treatment, patients are followed up periodically.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy, no Evidence of Disease
  • Dietary Supplement: cholecalciferol
    Given PO
    Other Names:
    • Calciol
    • Vitamin D3
  • Other: questionnaire administration
    Ancillary studies
  • Biological: trivalent influenza vaccine
    Given IM
    Other Names:
    • Flushield
    • Fluvirin
    • Fluzone
    • Influenza Vaccine
  • Experimental: Arm I (400 IU cholecalciferol and vaccine therapy)
    Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
    Interventions:
    • Dietary Supplement: cholecalciferol
    • Other: questionnaire administration
    • Biological: trivalent influenza vaccine
  • Experimental: Arm II (4,000 IU cholecalciferol and vaccine therapy)
    Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
    Interventions:
    • Dietary Supplement: cholecalciferol
    • Other: questionnaire administration
    • Biological: trivalent influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
211
Not Provided
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy individuals seen at the Employee Health Clinic who will be eligible to receive influenza vaccine Willingness to comply with study expectations Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure INTERVENTION COMPONENT ONLY: Willing to suspend use of any other vitamin D supplementation during the 3 month treatment interval; if currently using > 2,000 IU/day of vitamin D supplementation, must suspend use 30 days prior to enrollment

Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01561989
I 203111, NCI-2011-03232
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Martin Mahoney Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP