Healthy, no Evidence of Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
Given PO
OTHERquestionnaire administration
Ancillary studies
BIOLOGICALtrivalent influenza vaccine
Given IM
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of 25-hydroxy Vitamin D3 Levels on Immunologic Response (Antibody Responses) to Injectable Seasonal (2011-2012) Trivalent Influenza Vaccine (Observational Component) | At 4 weeks post-vaccination | 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. |
| Effect of Cholecalciferol Supplementation on Immunologic Response (Antibody Response) to Injectable Seasonal (2012-2013) Trivalent Influenza Vaccine (Intervention Component) | Up to 24 weeks post-vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrences of Flu-like Illness (Observational Component) | Up to April 1, 2012 | occurrences of flu-like illness |
| 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 | 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) |
| Occurrences of Flu-like Illnesses (Intervention Component) | From initial treatment until the end of study (April 1, 2012); up to 24-weeks. | occurrences of flu like illness (intervention arm) |
| 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 | 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) |
Countries
United States
Participant flow
Recruitment details
unable to meet accrual objective. study closed.
Pre-assignment details
unable to meet accrual objective. study closed.
Participants by arm
| Arm | Count |
|---|---|
| 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.
cholecalciferol: Given PO
questionnaire administration: Ancillary studies
trivalent influenza vaccine: Given IM | 5 |
| 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.
cholecalciferol: Given PO
questionnaire administration: Ancillary studies
trivalent influenza vaccine: Given IM | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | accural target not met. | 5 | 6 |
Baseline characteristics
| Characteristic | Arm I (400 IU Cholecalciferol and Vaccine Therapy) | Arm II (4,000 IU Cholecalciferol and Vaccine Therapy) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 5 Participants | 6 Participants | 11 Participants |
| Sex/Gender, Customized unknown | 5 participants | 6 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
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.
Time frame: At 4 weeks post-vaccination
Population: No subjects were treated prior to study closure due to lack of accrual.
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.
Time frame: Up to 24 weeks post-vaccination
Population: unable to accrue participants, study closed, no analyses completed.
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)
Time frame: Up to 24 weeks
Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
Secondary
Occurrences of Flu-like Illnesses (Intervention Component)
occurrences of flu like illness (intervention arm)
Time frame: From initial treatment until the end of study (April 1, 2012); up to 24-weeks.
Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
Secondary
Occurrences of Flu-like Illness (Observational Component)
occurrences of flu-like illness
Time frame: Up to April 1, 2012
Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.
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)
Time frame: Up to week 24
Population: No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.