Cholecalciferol and Flu Vaccine in Treating Healthy Participants

Healthy, no Evidence of Disease Clinical Trial

Official title:

Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01561989
• Other study ID #: I 203111
• Status: Terminated
• Phase: N/A
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: March 2020
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Exclusion criteria:

-not RPCI employee

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

Intervention

Dietary Supplement:
• cholecalciferol
Given PO

Other:
• questionnaire administration
Ancillary studies

Biological:
• trivalent influenza vaccine
Given IM

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of 25-hydroxy Vitamin D3 Levels on Immunologic Response (Antibody Responses) to Injectable Seasonal (2011-2012) Trivalent Influenza Vaccine (Observational Component)	Descriptive statistics and chi-square tests will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.	At 4 weeks post-vaccination
Primary	Effect of Cholecalciferol Supplementation on Immunologic Response (Antibody Response) to Injectable Seasonal (2012-2013) Trivalent Influenza Vaccine (Intervention Component)	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.	Up to 24 weeks post-vaccination
Secondary	Occurrences of Flu-like Illness (Observational Component)	occurrences of flu-like illness	Up to April 1, 2012
Secondary	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)	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)	Up to week 24
Secondary	Occurrences of Flu-like Illnesses (Intervention Component)	occurrences of flu like illness (intervention arm)	From initial treatment until the end of study (April 1, 2012); up to 24-weeks.
Secondary	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)	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)	Up to 24 weeks