Respiratory Tract InfectionsPhase 2/3ViDiFluNCT01069874
Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
A Phase 2/3 study testing Cholecalciferol (Vitamin D/Vigantol oil) and Miglyol oil in people with Respiratory Tract Infections and Influenza, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
Trial summary
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Influenza
- What is being tested?
- Cholecalciferol (Vitamin D/Vigantol oil) and Miglyol oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2010to Apr 2013
- Phase
- Phase 2/3
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Permanent resident or member of staff at sheltered accommodation unit
- If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
- Able to give written informed consent to participate
- Age ≥ 16 years on day of first dose of IMP
Who cannot join
- Current diagnosis of asthma or chronic obstructive pulmonary disease
- Chronic upper or lower respiratory infection or other condition causing chronic cough
- Condition requiring treatment with vitamin D at a dose of > 10 micrograms vitamin D/day
- Episode of upper or lower respiratory tract infection up to 28 days before first dose of IMP
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment
- Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
Show all 14Show fewer
- Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
- Using topical vitamin D analogue
- Treatment with any investigational medical product or device up to 4 months before first dose of IMP
- Breastfeeding, pregnant or planning a pregnancy
- Baseline corrected serum calcium > 2.65 mmol/L
- Baseline serum creatinine > 125 micromol/L
- Inability to complete symptom diary with / without assistance
- Cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hanover in Hackney Housing Association
London
Sanctuary Group Housing Association
London
About this study
Official title: Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu)
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
Read the detailed description
The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.
Participants will be followed for one year.
- Conditions
- Respiratory Tract Infections, Influenza
- Being tested
- Cholecalciferol (Vitamin D/Vigantol oil), Miglyol oil
- Keywords
- Bone Density Conservation Agents, Cholecalciferol, Communicable Diseases, Growth Substances, Housing for the Elderly, Infection, Micronutrients, Pharmacologic Actions, Physiological Effects of Drugs, Respiratory Tract Diseases, Vitamins, Respiratory Tract Infections/prevention & control*, Vitamin D
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, Communicable Diseases, Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (Vitamin D/Vigantol oil)Dietary supplement
Also called Vigantol oil
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oilDietary supplement
Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year
| Study group | Role | What they receive |
|---|---|---|
| Miglyol oil | Placebo comparator | Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year Receives: Dietary Supplement: Miglyol oil |
| Vigantol oil | Active comparator | Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year Receives: Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
Measured: One year
Secondary outcomes (4)
Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
Measured: One year
Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
Measured: One year
Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
Measured: One year
Proportion of participants experiencing hypercalcaemia
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionApr 2013
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 Respiratory Tract InfectionsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Adrian R Martineau, MRCP, Study director, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069874
- Sponsor's protocol ID
- 2009-010085-35
- Other IDs
- 2009
- Acronym
- ViDiFlu
- Status last verified
- Feb 2014
- First submitted
- 16 Feb 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martineau AR, Hanifa Y, Witt KD, Barnes NC, Hooper RL, Patel M, Stevens N, Enayat Z, Balayah Z, Syed A, Knight A, Jolliffe DA, Greiller CL, McLaughlin D, Venton TR, Rowe M, Timms PM, Clark D, Sadique Z, Eldridge SM, Griffiths CJ. Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). Thorax. 2015 Oct;70(10):953-60. doi: 10.1136/thoraxjnl-2015-206996. Epub 2015 Jun 10.
PubMed 26063508
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu)
- ClinicalTrials.gov ID
- NCT01069874
- Acronym / sponsor ID
- ViDiFlu / 2009-010085-35
- Conditions
- Respiratory Tract Infections, Influenza
- Keywords
- Bone Density Conservation Agents, Cholecalciferol, Communicable Diseases, Growth Substances, Housing for the Elderly, Infection, Micronutrients, Pharmacologic Actions
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Feb 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.
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
Detailed description
The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.
Participants will be followed for one year.
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 |
|---|---|---|
| Miglyol oil | Placebo comparator | Dietary Supplement: Miglyol oilMiglyol oil will be administered in 2-monthly oral bolus doses over a period of one year |
| Vigantol oil | Active comparator | Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil)Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Permanent resident or member of staff at sheltered accommodation unit
- If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
- Able to give written informed consent to participate
- Age ≥ 16 years on day of first dose of IMP
Key exclusion criteria (14 listed)
- Current diagnosis of asthma or chronic obstructive pulmonary disease
- Chronic upper or lower respiratory infection or other condition causing chronic cough
- Condition requiring treatment with vitamin D at a dose of > 10 micrograms vitamin D/day
- Episode of upper or lower respiratory tract infection up to 28 days before first dose of IMP
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment
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 |
|---|---|---|
| Cholecalciferol (Vitamin D/Vigantol oil)Also: Vigantol oilCholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year | Dietary supplement | Vigantol oil |
| Miglyol oilMiglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year | Dietary supplement | Miglyol oil |
Primary outcome
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
Time frame: One year
4 secondary outcomes
Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
Time frame: One year
Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
Time frame: One year
Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
Time frame: One year
Proportion of participants experiencing hypercalcaemia
Time frame: One year
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 4 Feb 2014.
- Derived from this study: PubMed 26063508Martineau AR, Hanifa Y, Witt KD, Barnes NC, Hooper RL, Patel M, Stevens N, Enayat Z, Balayah Z, Syed A, Knight A, Jolliffe DA, Greiller CL, McLaughlin D, Venton TR, Rowe M, Timms PM, Clark D, Sadique Z, Eldridge SM, Griffiths CJ. Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). Thorax. 2015 Oct;70(10):953-60. doi: 10.1136/thoraxjnl-2015-206996. Epub 2015 Jun 10.
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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.
Adrian R Martineau, MRCP study director
Queen Mary University of London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cholecalciferol (Vitamin D/Vigantol oil) and Miglyol oil in people with Respiratory Tract Infections and Influenza, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
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 4 inclusion and 14 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 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents (time frame: One year). 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 NCT01069874, 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 4 Feb 2014.