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Vitamin D and Staphylococcus Aureus in the Diabetes Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395290
First Posted: July 15, 2011
Last Update Posted: September 5, 2012
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.
Information provided by (Responsible Party):
University of Tromso
  Purpose
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
Infection Drug: cholecalciferol Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Tromso:

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

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

  Eligibility

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
Criteria

Inclusion Criteria:

  • participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

  • none specifically for this study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01395290


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

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01395290     History of Changes
Other Study ID Numbers: UIT-ENDO-2011-1
First Submitted: July 14, 2011
First Posted: July 15, 2011
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by University of Tromso:
staphylococcus aureus
vitamin D

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