Vitamin D and Staphylococcus Aureus in the Diabetes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01395290
First received: July 14, 2011
Last updated: September 3, 2012
Last verified: September 2012
  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
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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Tromso
ClinicalTrials.gov 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:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 28, 2014