Healthy, no Evidence of DiseaseNCT01561989
Cholecalciferol and Flu Vaccine in Treating Healthy Participants
A study testing cholecalciferol, questionnaire administration and trivalent influenza vaccine in people with Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- cholecalciferol, questionnaire administration and trivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -not RPCI employee
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- cholecalciferol, questionnaire administration, trivalent influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called Calciol, Vitamin D3
Given PO
questionnaire administrationOther
Ancillary studies
trivalent influenza vaccineBiological
Also called Flushield, Fluvirin, Fluzone, Influenza Vaccine
Given IM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: cholecalciferol; Other: questionnaire administration; Biological: trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 weeks post-vaccination
Secondary outcomes (4)
Occurrences of Flu-like Illness (Observational Component)
occurrences of flu-like illness
Measured: 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)
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)
Measured: Up to week 24
Occurrences of Flu-like Illnesses (Intervention Component)
occurrences of flu like illness (intervention arm)
Measured: 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)
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJun 2015
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Martin Mahoney, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561989
- Sponsor's protocol ID
- I 203111
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2012
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status
- ClinicalTrials.gov ID
- NCT01561989
- Acronym / sponsor ID
- I 203111
- Conditions
- Healthy, no Evidence of Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (400 IU cholecalciferol and vaccine therapy) | Experimental | Dietary Supplement: cholecalciferol, Other: questionnaire administration, Biological: trivalent influenza vaccinePatients 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 | Dietary Supplement: cholecalciferol, Other: questionnaire administration, Biological: trivalent influenza vaccinePatients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -not RPCI employee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: Calciol, Vitamin D3Given PO | Dietary supplement | Arm I (400 IU cholecalciferol and vaccine therapy), Arm II (4,000 IU cholecalciferol and vaccine therapy) |
| questionnaire administrationAncillary studies | Other | Arm I (400 IU cholecalciferol and vaccine therapy), Arm II (4,000 IU cholecalciferol and vaccine therapy) |
| trivalent influenza vaccineAlso: Flushield, Fluvirin, Fluzone, Influenza VaccineGiven IM | Biological | Arm I (400 IU cholecalciferol and vaccine therapy), Arm II (4,000 IU cholecalciferol and vaccine therapy) |
Primary outcome
Effect of 25-hydroxy Vitamin D3 Levels on Immunologic Response (Antibody Responses) to Injectable Seasonal (2011-2012) Trivalent Influenza Vaccine (Observational Component)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Occurrences of Flu-like Illness (Observational Component)
Time frame: 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)
Time frame: Up to week 24
Occurrences of Flu-like Illnesses (Intervention Component)
Time frame: 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)
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Mahoney principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol, questionnaire administration and trivalent influenza vaccine in people with Healthy, no Evidence of Disease, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 25-hydroxy Vitamin D3 Levels on Immunologic Response (Antibody Responses) to Injectable Seasonal (2011-2012) Trivalent Influenza Vaccine (Observational Component) (time frame: At 4 weeks post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.