Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigantol oil | Active Comparator | Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year |
|
| Miglyol oil | Placebo Comparator | Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first upper respiratory tract infection | One year | |
| Time to first moderate / severe COPD exacerbation | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease | One year | |
| Proportion of participants experiencing hypercalcaemia | One year |
Not provided
Principal Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian R Martineau, MRCP | Queen Mary University of London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lower Clapton Health Centre | London | E5 0PD | United Kingdom | |||
| Homerton University Hospital NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25476069 | Derived | Martineau AR, James WY, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Islam K, McLaughlin D, Bhowmik A, Timms PM, Rajakulasingam RK, Rowe M, Venton TR, Choudhury AB, Simcock DE, Wilks M, Degun A, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2015 Feb;3(2):120-130. doi: 10.1016/S2213-2600(14)70255-3. Epub 2014 Dec 2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miglyol oil | Dietary Supplement | Miglyol oil will be administered in 2-monthly bolus doses over a period of one year |
|
| London |
| E9 6SR |
| United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 | United Kingdom |
| Barts and The London NHS Trust | London | United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |