Cholecalciferol and Flu Vaccine in Treating Healthy Participants

NCT01561989 | Terminated Results DMC

• 1 other identifier: I 203111
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Occurrences of Flu-like Illness (Observational Component)

  Up to April 1, 2012

• 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

• Occurrences of Flu-like Illnesses (Intervention Component)

  From initial treatment until the end of study (April 1, 2012); up to 24-weeks.

• 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

Study Arms (2)

Arm I (400 IU cholecalciferol and vaccine therapy)

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: Calciol, Vitamin D3

Arm I (400 IU cholecalciferol and vaccine therapy); Arm II (4,000 IU cholecalciferol and vaccine therapy)

questionnaire administration OTHER

Ancillary studies

Arm I (400 IU cholecalciferol and vaccine therapy); Arm II (4,000 IU cholecalciferol and vaccine therapy)

trivalent influenza vaccine BIOLOGICAL

Given IM

Also known as: Flushield, Fluvirin, Fluzone, Influenza Vaccine

Arm I (400 IU cholecalciferol and vaccine therapy); Arm II (4,000 IU cholecalciferol and vaccine therapy)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• not RPCI employee

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Cholecalciferol; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

unable to meet accrual objective. study closed. No analyses or followup was completed.

Results Point of Contact

• Title: Dr. Martin Mahoney
• Organization: Roswell Park Cancer Institute

martin.mahoney@roswellpark.org

716-845-2300

Study Officials

• Martin Mahoney

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 23, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: June 1, 2015
• Last Updated: March 10, 2020
• Results First Posted: March 10, 2020

Record last verified: 2020-03

Locations

US (1)