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low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Flu-like Illness (Observational Component) | occurrences of flu-like illness | 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) |
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Inclusion Criteria:
Exclusion criteria:
-not RPCI employee
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| Name | Affiliation | Role |
|---|---|---|
| Martin Mahoney | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
unable to meet accrual objective. study closed.
unable to meet accrual objective. study closed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM. Unable to meet accrual objective. Arm closed with study termination. |
| FG001 | Arm II | Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM. Unable to meet accrual objective. Arm closed with study termination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No subjects were treated prior to study closure due to lack of accrual. | Posted | At 4 weeks post-vaccination |
|
Subjects would be evaluated for AEs from the initial treatment until April 1, 2012; which is a time-period of up to 24-weeks. However, no subjects were treated prior to study closure due to lack of accrual and no AEs were recorded.
study terminated prior to any intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cholecalciferal + Flu Vaccine | unable to meet accrual objective. study closed prior to delivery of any intervention. No analyses or followup. |
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unable to meet accrual objective. study closed. No analyses or followup was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Mahoney | Roswell Park Cancer Institute | 716-845-2300 | martin.mahoney@roswellpark.org |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| questionnaire administration | Other | Ancillary studies |
|
| trivalent influenza vaccine | Biological | Given IM |
|
|
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) | occurrences of flu like illness (intervention arm) | 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) | 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
|
| 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. | unable to accrue participants, study closed, no analyses completed. | Posted | Up to 24 weeks post-vaccination |
|
|
| Secondary | Occurrences of Flu-like Illness (Observational Component) | occurrences of flu-like illness | 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. | Posted | 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) | 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. | Posted | Up to week 24 |
|
|
| Secondary | Occurrences of Flu-like Illnesses (Intervention Component) | occurrences of flu like illness (intervention arm) | 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. | Posted | 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) | 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. | Posted | Up to 24 weeks |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Flu Vaccine Alone | unable to meet accrual objective. study closed prior to delivery of intervention. No analyses or followup. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |