Vitamin D and Staphylococcus Aureus in the Diabetes Study | NCT01395290

Studies
Vitamin D and Staphylococcus Aureus in the Diabetes Study

NCT01395290

Sponsor

University of Tromso

Status

Completed

Last Update Posted

Sep 5, 2012Estimated

Enrollment

280Actual

Phase

Phase 3

Conditions

Infection

Interventions

cholecalciferol

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 14, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2012

Last Update Posted Date

Sep 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cholecalciferol	Experimental	cholecalciferol 20.000 IU per week	Drug: cholecalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecalciferol	Drug	20.000 IU per week, oral	cholecalciferol

Measure	Description	Time Frame
nasal staphylococcus colonisation		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

none specifically for this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolf Jorde, Professor	University of Tromso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø	Tromsø	9038	Norway

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D013203	Staphylococcal Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided