Vitamin D and Staphylococcus Aureus in the Diabetes Study

This study has been completed.
Information provided by (Responsible Party):
University of Tromso Identifier:
First received: July 14, 2011
Last updated: September 3, 2012
Last verified: September 2012
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 Intervention Phase
Drug: cholecalciferol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Staphylococcus Aureus in the Diabetes Study

Resource links provided by NLM:

Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • nasal staphylococcus colonisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cholecalciferol
cholecalciferol 20.000 IU per week
Drug: cholecalciferol
20.000 IU per week, oral


Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

  • none specifically for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01395290

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

Responsible Party: University of Tromso Identifier: NCT01395290     History of Changes
Other Study ID Numbers: UIT-ENDO-2011-1 
Study First Received: July 14, 2011
Last Updated: September 3, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Tromso:
staphylococcus aureus
vitamin D

Additional relevant MeSH terms:
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs
Vitamins processed this record on May 26, 2016