Clinical trial · Interventional
Cholecalciferol and Flu Vaccine in Treating Healthy Participants
Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status
NCT01561989CI-TRIAL-00043933terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| trivalent influenza vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (400 IU cholecalciferol and vaccine therapy)
- description
- Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
- interventionNames
- Dietary Supplement: cholecalciferol
- Other: questionnaire administration
- Biological: trivalent influenza vaccine
- type
- EXPERIMENTAL
- label
- Arm II (4,000 IU cholecalciferol and vaccine therapy)
- description
- Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.
- interventionNames
- Dietary Supplement: cholecalciferol
- Other: questionnaire administration
- Biological: trivalent influenza vaccine
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.