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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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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.
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| 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 severe asthma exacerbation | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test Score | One year | |
| Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation | One year | |
| Proportion of participants experiencing hypercalcaemia |
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Principal Inclusion Criteria:
Principal Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian R Martineau, MRCP | Queen Mary University of London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and The London NHS Trust | London | London | E1 1BB | United Kingdom | ||
| Lower Clapton Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25724847 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Miglyol oil | Dietary Supplement | Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year |
|
| One year |
| London |
| London |
| E5 0PD |
| United Kingdom |
| Homerton University Hospital NHS Foundation Trust | London | London | E9 6SR | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | London | SE1 9RT | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |