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Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men

Primary Purpose

Vitamin D Deficiency, Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria;

  • Male
  • 18-29 years of age
  • examined as Healthy according to Finnish Military Health Care regulations

Exclusion Criteria

  • Female
  • age > 30 yrs

Sites / Locations

  • Finnish Defence Forces

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D3

Placebo

Arm Description

20 mikrog vitamin D3 daily, 3 months

Placebo

Outcomes

Primary Outcome Measures

Days off duty due to acute respiratory tract infections
The number of Days off Duty recommended by Health care personnel will be calculated in order to show the severity and last of the disease. By that it could be estimated how the disease will effect on duty service.

Secondary Outcome Measures

Days off duty due to musculoskeletal disorders
The number of days off Duty because of musculoskeletal disorders will be index for outcome. The index will be compared between plasebo and intervention group
Aerobic and muscular fitness
Used test are Cooper-test for aerobic and Finnish military fitness test for muscular fitness performance. The index will be compared between plasebo and intervention group

Full Information

First Posted
December 16, 2020
Last Updated
October 17, 2023
Sponsor
Tampere University
Collaborators
Finnish Defense Forces
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1. Study Identification

Unique Protocol Identification Number
NCT05014048
Brief Title
Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men
Official Title
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infection: a Randomized, Double-blinded and Plasebo Controlled Trial Among Young Finnish Men
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
May 14, 2018 (Actual)
Study Completion Date
May 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Finnish Defense Forces

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Respiratory Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D3
Arm Type
Active Comparator
Arm Description
20 mikrog vitamin D3 daily, 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
20 mikrog vitamin D3 daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Days off duty due to acute respiratory tract infections
Description
The number of Days off Duty recommended by Health care personnel will be calculated in order to show the severity and last of the disease. By that it could be estimated how the disease will effect on duty service.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Days off duty due to musculoskeletal disorders
Description
The number of days off Duty because of musculoskeletal disorders will be index for outcome. The index will be compared between plasebo and intervention group
Time Frame
4 months
Title
Aerobic and muscular fitness
Description
Used test are Cooper-test for aerobic and Finnish military fitness test for muscular fitness performance. The index will be compared between plasebo and intervention group
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria; Male 18-29 years of age examined as Healthy according to Finnish Military Health Care regulations Exclusion Criteria Female age > 30 yrs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ilkka laaksi, MDPhD
Organizational Affiliation
University of Tampere, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finnish Defence Forces
City
Hämeenlinna
ZIP/Postal Code
13210
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men

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