Cholecalciferol and Flu Vaccine in Treating Healthy Participants

Roswell Park Comprehensive Cancer Center

Status: Terminated

Conditions: Healthy, no Evidence of Disease

Treatments: Dietary Supplement: cholecalciferol; Other: questionnaire administration; Biological: trivalent influenza vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01561989

I 203111

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Arm I (400 IU cholecalciferol and vaccine therapy)

Experimental group

Description:

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

Treatment:

Other: questionnaire administration

Biological: trivalent influenza vaccine

Dietary Supplement: cholecalciferol

Arm II (4,000 IU cholecalciferol and vaccine therapy)

Experimental group

Description:

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

Treatment:

Other: questionnaire administration

Biological: trivalent influenza vaccine

Dietary Supplement: cholecalciferol