Vitamin D Supplementation for the Prevention of Acute Res... | NCT00973583

Studies
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

NCT00973583

Sponsor

Tampere University

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

164Actual

Phase

Not Applicable

Conditions

Respiratory Tract Infections

Interventions

vitamin D
placebo

Countries

Finland

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

Dec 2014

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

May 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

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

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Name	Class
Finnish Defense Forces	OTHER_GOV

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

The investigators earlier clinical study in 754 young Finnish men demonstrated a significant negative association of serum 25-OHD concentration with acute respiratory tract infections. The present study aimed to determine whether vitamin D supplementation may decrease the incidence of acute respiratory tract infections.

Detailed Description

Subjects comprised 164 male conscripts at a military base in Finland. Half of the participants were randomly allocated to receive 400 IU vitamin D daily and half received placebo from October through March. Serum vitamin D and plasma parathyroid hormone concentrations were determined. Subjects were followed for 6 months and the primary outcome was the number of days absent from duty due to ARTI.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D	Active Comparator		Dietary Supplement: vitamin D
placebo	Placebo Comparator		Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D	Dietary Supplement	vitamin D3 400 IU daily	vitamin D	Minisun

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of days absent from duty due to respiratory tract infection		6 months

Secondary Outcomes

Measure	Description	Time Frame
The proportion of men remaining healthy throughout the 6-month study period		6 months
The number needed to treat calculated from the proportion of men without any days absent from duty		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Use vitamin D

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ilkka T Laaksi, M.D.	Tampere University	Principal Investigator
Harri Pihlajamaki, Docent	Research Department, Centre for Military Medicine, Helsinki, Finland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
university of Tampere		Tampere		33014	Finland

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided