InfluenzaPhase 3NCT01182870
Vitamin D and the Influenza Epidemic
A Phase 3 study testing choleclaciferol in people with Influenza, run by University of Tromso at 1 site in Norway.
Trial summary
Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- choleclaciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 569 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 3
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participant in vitamin D versus placebo study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.
- Conditions
- Influenza
- Being tested
- choleclaciferol
- Keywords
- vitamin D, influenza, prevention
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choleclaciferolDrug
800-6000 IU cholecalciferol per day
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Experimental | cholecalciferol in doses 800-6000 IU per day Receives: Drug: choleclaciferol |
| placebo | Placebo comparator | placebo identical looking as cholecalciferol capsules Receives: Drug: choleclaciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza during the winter season 2009/2010
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Investigators
- rolf Jorde, md, Principal investigator, University of Tromso, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182870
- Sponsor's protocol ID
- UIT-ENDO-2010-1
- Status last verified
- Jul 2011
- First submitted
- 11 Aug 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and the Influenza Epidemic
- ClinicalTrials.gov ID
- NCT01182870
- Acronym / sponsor ID
- UIT-ENDO-2010-1
- Conditions
- Influenza
- Keywords
- vitamin D, influenza, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- 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.
Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.
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 |
|---|---|---|
| cholecalciferol | Experimental | Drug: choleclaciferolcholecalciferol in doses 800-6000 IU per day |
| placebo | Placebo comparator | Drug: choleclaciferolplacebo identical looking as cholecalciferol capsules |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participant in vitamin D versus placebo study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| choleclaciferol800-6000 IU cholecalciferol per day | Drug | cholecalciferol, placebo |
Primary outcome
influenza during the winter season 2009/2010
Time frame: up to 30 weeks
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 20 Jul 2011.
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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.
rolf Jorde, md principal investigator
University of Tromso, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing choleclaciferol in people with Influenza, run by University of Tromso at 1 site in Norway.
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 1 inclusion and 1 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 20 Jul 2011. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
influenza during the winter season 2009/2010 (time frame: up to 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.