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Vitamin D and the Influenza Epidemic

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
choleclaciferol
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring vitamin D, influenza, prevention

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participant in vitamin D versus placebo study

Exclusion Criteria:

  • none

Sites / Locations

  • University of Tromsø

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

cholecalciferol

placebo

Arm Description

cholecalciferol in doses 800-6000 IU per day

placebo identical looking as cholecalciferol capsules

Outcomes

Primary Outcome Measures

influenza during the winter season 2009/2010

Secondary Outcome Measures

Full Information

First Posted
August 11, 2010
Last Updated
July 19, 2011
Sponsor
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT01182870
Brief Title
Vitamin D and the Influenza Epidemic
Official Title
Vitamin D and the Influenza Epidemic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
vitamin D, influenza, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cholecalciferol
Arm Type
Experimental
Arm Description
cholecalciferol in doses 800-6000 IU per day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo identical looking as cholecalciferol capsules
Intervention Type
Drug
Intervention Name(s)
choleclaciferol
Intervention Description
800-6000 IU cholecalciferol per day
Primary Outcome Measure Information:
Title
influenza during the winter season 2009/2010
Time Frame
up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participant in vitamin D versus placebo study Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rolf Jorde, md
Organizational Affiliation
University of Tromso, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tromsø
City
Tromsø
ZIP/Postal Code
9037
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Vitamin D and the Influenza Epidemic

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