Cholecalciferol and Flu Vaccine in Treating Healthy Participants

NCT ID: NCT01561989

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-06-30

Brief 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

Detailed 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.

Conditions

Healthy, no Evidence of Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

questionnaire administration

Intervention Type: OTHER

Ancillary studies

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Given IM

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.

Group Type: EXPERIMENTAL

cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

questionnaire administration

Intervention Type: OTHER

Ancillary studies

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Given IM

Interventions

cholecalciferol

Given PO

Intervention Type: DIETARY_SUPPLEMENT

questionnaire administration

Ancillary studies

Intervention Type: OTHER

trivalent influenza vaccine

Given IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Calciol; Vitamin D3; Flushield; Fluvirin; Fluzone; Influenza Vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Mahoney

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

I 203111

Identifier Type: -

Identifier Source: org_study_id