Vitamin D and Staphylococcus Aureus in the Diabetes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395290
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : September 5, 2012
Information provided by (Responsible Party):
University of Tromso

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.

Condition or disease Intervention/treatment Phase
Infection Drug: cholecalciferol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Staphylococcus Aureus in the Diabetes Study
Study Start Date : April 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: cholecalciferol
cholecalciferol 20.000 IU per week
Drug: cholecalciferol
20.000 IU per week, oral

Primary Outcome Measures :
  1. nasal staphylococcus colonisation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

  • none specifically for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395290

University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University of Tromso
Principal Investigator: Rolf Jorde, Professor University of Tromso

Responsible Party: University of Tromso Identifier: NCT01395290     History of Changes
Other Study ID Numbers: UIT-ENDO-2011-1
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by University of Tromso:
staphylococcus aureus
vitamin D

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents