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

Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infection: a Randomized, Double-blinded and Plasebo Controlled Trial Among Young Finnish Men

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

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Hämeenlinna, Finland, 13210
    • Finnish Defence Forces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria;

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

Exclusion Criteria

• Female
• age > 30 yrs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Active Comparator: vitamin D3; 20 mikrog vitamin D3 daily, 3 months	Dietary supplement: Vitamin D3; 20 mikrog vitamin D3 daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months
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	4 months

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Finnish Defense Forces
• Investigators: Principal Investigator: ilkka laaksi, MDPhD, University of Tampere, Finland

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): May 14, 2018
• Study Completion (Actual): May 14, 2018

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Infections; Communicable Diseases; Vitamin D Deficiency; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: UTampere

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No