Vitamin D and Staphylococcus Aureus in the Diabetes Study

September 3, 2012 updated by: University of Tromso
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

  • none specifically for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cholecalciferol
cholecalciferol 20.000 IU per week
Drug: cholecalciferol
20.000 IU per week, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nasal staphylococcus colonisation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIT-ENDO-2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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