Back to resultsVitamin D and Staphylococcus Aureus in the Diabetes Study
Primary Purpose
Infection
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring staphylococcus aureus, vitamin D
Eligibility Criteria
Inclusion Criteria:
- participant in an ongoing intervention study with vitamin D
Exclusion Criteria:
- none specifically for this study
Sites / Locations
- University Hospital of North Norway
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cholecalciferol
Arm Description
cholecalciferol 20.000 IU per week
Outcomes
Primary Outcome Measures
nasal staphylococcus colonisation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01395290
Brief Title
Vitamin D and Staphylococcus Aureus in the Diabetes Study
Official Title
Vitamin D and Staphylococcus Aureus in the Diabetes Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are indications that the vitamin D status of an individual is related to susceptibility to staphylococcal infections. In the present study we will examine nasal colonisation rate in subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose tolerance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
staphylococcus aureus, vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cholecalciferol
Arm Type
Experimental
Arm Description
cholecalciferol 20.000 IU per week
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Intervention Description
20.000 IU per week, oral
Primary Outcome Measure Information:
Title
nasal staphylococcus colonisation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participant in an ongoing intervention study with vitamin D
Exclusion Criteria:
none specifically for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Jorde, Professor
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Vitamin D and Staphylococcus Aureus in the Diabetes Study
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