Vitamin D DeficiencyNCT05014048
Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men
A study testing Vitamin D3 in people with Vitamin D Deficiency and Respiratory Tract Infections, run by Tampere University at 1 site in Finland.
Trial summary
Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Respiratory Tract Infections
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteFinland
- Study dates
- 4 Jan 2018to 14 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-29 years of age
- examined as Healthy according to Finnish Military Health Care regulations
Who cannot join
- Female
- age > 30 yrs
Trial locations and contacts
1 site in 1 country.
About this study
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
Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men
- Conditions
- Vitamin D Deficiency, Respiratory Tract Infections
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Vitamin D Deficiency, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
20 mikrog vitamin D3 daily
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 | Active comparator | 20 mikrog vitamin D3 daily, 3 months Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start4 Jan 2018
- Primary completion14 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Defense Forces
- Responsible party
- Principal investigator, Ilkka Laaksi, Tampere University
- Investigators
- ilkka laaksi, MDPhD, Principal investigator, University of Tampere, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014048
- Sponsor's protocol ID
- UTampere
- Status last verified
- Oct 2023
- First submitted
- 16 Dec 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Laaksi A, Kyrolainen H, Pihlajamaki H, Vaara JP, Luukkaala T, Laaksi I. Effects of Vitamin D Supplementation and Baseline Vitamin D Status on Acute Respiratory Infections and Cathelicidin: A Randomized Controlled Trial. Open Forum Infect Dis. 2024 Aug 27;11(9):ofae482. doi: 10.1093/ofid/ofae482. eCollection 2024 Sep.
PubMed 39301110
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05014048
- Acronym / sponsor ID
- UTampere
- Conditions
- Vitamin D Deficiency, Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Finnish Defense Forces
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 | Active comparator | Dietary Supplement: Vitamin D320 mikrog vitamin D3 daily, 3 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-29 years of age
- examined as Healthy according to Finnish Military Health Care regulations
Key exclusion criteria (2 listed)
- Female
- age > 30 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D320 mikrog vitamin D3 daily | Dietary supplement | vitamin D3 |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Days off duty due to acute respiratory tract infections
Time frame: 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.
2 secondary outcomes
Days off duty due to musculoskeletal disorders
Time frame: 4 months
Aerobic and muscular fitness
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 39301110Laaksi A, Kyrolainen H, Pihlajamaki H, Vaara JP, Luukkaala T, Laaksi I. Effects of Vitamin D Supplementation and Baseline Vitamin D Status on Acute Respiratory Infections and Cathelicidin: A Randomized Controlled Trial. Open Forum Infect Dis. 2024 Aug 27;11(9):ofae482. doi: 10.1093/ofid/ofae482. eCollection 2024 Sep.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ilkka laaksi, MDPhD principal investigator
University of Tampere, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Vitamin D Deficiency and Respiratory Tract Infections, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days off duty due to acute respiratory tract infections (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.