AsthmaPhase 2/3ViDiAsNCT00978315
Trial of Vitamin D Supplementation in Asthma
A Phase 2/3 study testing Cholecalciferol and Miglyol oil in people with Asthma, run by Barts & The London NHS Trust at 4 sites in United Kingdom.
Trial summary
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Cholecalciferol 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
- 250 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Sep 2009to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Principal Inclusion Criteria:
- Medical record diagnosis of asthma
- Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
- 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 in the study
Principal Exclusion Criteria:
- Diagnosis of COPD
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
- Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
- Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
- Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
- 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
- Smoking history >15 pack-years
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Barts and The London NHS Trust
London, London, E1 1BB
Lower Clapton Health Centre
London, London, E5 0PD
Homerton University Hospital NHS Foundation Trust
London, London, E9 6SR
Guy's and St Thomas' NHS Foundation Trust
London, London, SE1 9RT
About this study
Official title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.
- Conditions
- Asthma
- Being tested
- Cholecalciferol, Miglyol oil
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
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 Vigantol oil over a period of one year
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first upper respiratory tract infection
Measured: One year
Time to first severe asthma exacerbation
Measured: One year
Secondary outcomes (3)
Asthma Control Test Score
Measured: One year
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation
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 posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2013
- Study completionJul 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 AsthmaStudies 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
- 250 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
- NCT00978315
- Sponsor's protocol ID
- 2009-010083-42
- Other IDs
- 2009
- Acronym
- ViDiAs
- Status last verified
- Feb 2014
- First submitted
- 14 Sep 2009
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.
PubMed 25724847
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
- Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
- ClinicalTrials.gov ID
- NCT00978315
- Acronym / sponsor ID
- ViDiAs / 2009-010083-42
- Conditions
- Asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Sep 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Sep 2009 (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.
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.
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 |
|---|---|---|
| Vigantol oil | Active comparator | Dietary Supplement: CholecalciferolVigantol oil will be administered in 2-monthly oral bolus doses over a period of one year |
| Miglyol oil | Placebo comparator | Dietary Supplement: Miglyol oilMiglyol oil will be administered in 2-monthly oral bolus doses over a period of one year |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CholecalciferolCholecalciferol 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 Vigantol oil over a period of one year | Dietary supplement | Miglyol oil |
Primary outcome
Time to first upper respiratory tract infection
Time frame: One year
Time to first severe asthma exacerbation
Time frame: One year
3 secondary outcomes
Asthma Control Test Score
Time frame: One year
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation
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 25724847Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.
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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
4 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 and Miglyol oil in people with Asthma, run by Barts & The London NHS Trust at 4 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?
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 4 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 upper respiratory tract infection (time frame: One year). The study lists 2 primary outcomes in all. 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 NCT00978315, 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.