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Previous research has shown that people who have been hospitalised for pneumonia are more likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months after their illness. This risk is linked to raised levels of inflammation. Laboratory research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very common in the United Kingdom. The investigators are conducting this study to find out if taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate supplementation | Active Comparator | Dietary supplement: Vitamin D3 supplementation - oral capsules 6400 International Units once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire |
|
| Delayed supplementation | Placebo Comparator | Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 supplementation | Dietary Supplement | Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma IL-6 concentrations | IL-6 | after 6 weeks of vitamin D3 supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Serum CRP | CRP | after 6 weeks of vitamin D3 supplementation |
| Total white cell count and differential white cell count in induced sputum samples | WBC and differential counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Martineau, MBBS | Queen Mary University of London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | E1 1BB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18369199 | Background | Yende S, D'Angelo G, Kellum JA, Weissfeld L, Fine J, Welch RD, Kong L, Carter M, Angus DC; GenIMS Investigators. Inflammatory markers at hospital discharge predict subsequent mortality after pneumonia and sepsis. Am J Respir Crit Care Med. 2008 Jun 1;177(11):1242-7. doi: 10.1164/rccm.200712-1777OC. Epub 2008 Mar 27. | |
| 22942205 |
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|
| Peripheral blood and induced sputum sampling | Biological | To attain samples for immunological testing |
|
| Chest computerised tomography (CT) scans | Radiation | For volumetric quantification of lung abnormalities |
|
| Symptom questionnaire | Other | Symptom questionnaire for recent symptom history |
|
| Placebo | Other | To be dispensed using an electronic dispenser to allow real time logging of adherence. |
|
| after 6 weeks of vitamin D3 supplementation |
| Immune cell phenotypes in peripheral blood | flow cytometry phenotypes, blood | after 6 weeks of vitamin D3 supplementation |
| Immune cell phenotypes in induced sputum samples | flow cytometry phenotypes, induced sputum | after 6 weeks of vitamin D3 supplementation |
| Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood | Cytokines, lipid mediators, blood | after 6 weeks of vitamin D3 supplementation |
| Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples | Cytokines, lipid mediators, induced sputum | after 6 weeks of vitamin D3 supplementation |
| Plasma concentrations of pro- and anti-inflammatory mediators in supernatants from whole blood stimulated with antigens ex-vivo | Cytokines, lipid mediators, stimulated blood | after 6 weeks of vitamin D3 supplementation |
| Whole blood transcriptional profiles | mRNA | after 6 weeks of vitamin D3 supplementation |
| Volumes of lung abnormalities on chest CT imaging | CT data | after 6 weeks of vitamin D3 supplementation |
| Pneumonia symptom scores | CAP-Sym scores | after 6 weeks of vitamin D3 supplementation |
| Remmelts HH, van de Garde EM, Meijvis SC, Peelen EL, Damoiseaux JG, Grutters JC, Biesma DH, Bos WJ, Rijkers GT. Addition of vitamin D status to prognostic scores improves the prediction of outcome in community-acquired pneumonia. Clin Infect Dis. 2012 Dec;55(11):1488-94. doi: 10.1093/cid/cis751. Epub 2012 Aug 31. |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D003289 | Convalescence |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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