NCT01395290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

July 14, 2011

Last Update Submit

September 3, 2012

Conditions

Infection

Keywords

staphylococcus aureusvitamin D

Outcome Measures

Primary Outcomes (1)

  • nasal staphylococcus colonisation

    6 months

Study Arms (1)

cholecalciferol

EXPERIMENTAL

cholecalciferol 20.000 IU per week

Drug: cholecalciferol

Interventions

cholecalciferolDRUG

20.000 IU per week, oral

cholecalciferol

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participant in an ongoing intervention study with vitamin D

You may not qualify if:

  • none specifically for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

InfectionsStaphylococcal Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Rolf Jorde, Professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 15, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

NO(1)