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

• Sponsor: Tampere University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05014048
• Collaborator: Finnish Defense Forces (Other)
• Enrollment: 800
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46.9
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Respiratory Tract Infections	Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 4, 2018
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Days off duty due to acute respiratory tract infections [4 months]

   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

1. Days off duty due to musculoskeletal disorders [4 months]

   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

2. Aerobic and muscular fitness [4 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria;

• Male

• 18-29 years of age

• examined as Healthy according to Finnish Military Health Care regulations

Exclusion Criteria

• Female

• age > 30 yrs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Finnish Defence Forces	Hämeenlinna		Finland	13210

Sponsors and Collaborators

• Tampere University
• Finnish Defense Forces

Investigators

• Principal Investigator: ilkka laaksi, MDPhD, University of Tampere, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilkka Laaksi, Principal Investigator, Tampere University
• ClinicalTrials.gov Identifier: NCT05014048
• Other Study ID Numbers: UTampere
• First Posted: Aug 20, 2021
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Aug 20, 2021