Pneumonia
Conditions
Keywords
convalescence, inflammation, resolution, vitamin D
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3 supplementation
Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.
BIOLOGICALPeripheral blood and induced sputum sampling
To attain samples for immunological testing
RADIATIONChest computerised tomography (CT) scans
For volumetric quantification of lung abnormalities
Symptom questionnaire for recent symptom history
OTHERPlacebo
To be dispensed using an electronic dispenser to allow real time logging of adherence.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥50 years of age 2. Vitamin D deficiency at entry, defined as a serum total 25(OH)D concentration \<50 nmol/L 3. Admission to hospital with an acute illness (≤21 days) consistent with community-acquired pneumonia - at least one symptom of a lower respiratory tract infection (cough, sputum production, dyspnoea, wheeze, chest discomfort or pain, fever) and new infiltrate on chest radiograph 4. Adequate mental capacity to give informed consent for participation in the study and gives written informed consent
Exclusion criteria
1. Currently taking any vitamin D supplementation 2. Known HIV infection, other condition causing immunosuppression, current immunosuppressive therapy or systemic corticosteroids 3. Known malignancy not in remission for \>3 years or terminal illness with prognosis \<1year 4. History of smoking within the previous 1 year 5. Known or suspected diagnosis of chronic obstructive pulmonary disease (COPD) 6. Previous hospitalisation within 10 days of admission 7. Aspiration pneumonia diagnosed by the clinical team 8. Known diagnosis of cystic fibrosis, bronchiectasis or interstitial lung disease at screening 9. Complications of pneumonia such as empyema or lung abscess at entry 10. Recent acute coronary syndrome within the previous 1 month 11. Long term oxygen therapy, chronic mechanical ventilation dependency or other contraindication to sputum induction 12. Serum corrected calcium concentration \>2.65 mmol/L at entry 13. Chronic kidney disease stage 4-5 (estimated glomerular filtration rate \<30ml/min) on an existing blood sample from the current hospital admission 14. Known clinical diagnosis of liver failure 15. Known or suspected diagnosis of active pulmonary tuberculosis 16. Known diagnosis of primary hyperparathyroidism 17. Known diagnosis of sarcoidosis 18. Known diagnosis of nephrolithiasis 19. Taking carbamazepine, phenytoin, phenobarbital, primidone, cardiac glycosides or benzothiadiazines with concomitant calcium supplementation at entry 20. Known allergy to vitamin D or its excipients 21. Currently taking part in another research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma IL-6 concentrations | after 6 weeks of vitamin D3 supplementation | IL-6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total white cell count and differential white cell count in induced sputum samples | after 6 weeks of vitamin D3 supplementation | WBC and differential counts |
| Immune cell phenotypes in peripheral blood | after 6 weeks of vitamin D3 supplementation | flow cytometry phenotypes, blood |
| Immune cell phenotypes in induced sputum samples | after 6 weeks of vitamin D3 supplementation | flow cytometry phenotypes, induced sputum |
| Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood | after 6 weeks of vitamin D3 supplementation | Cytokines, lipid mediators, blood |
| Serum CRP | after 6 weeks of vitamin D3 supplementation | CRP |
| Plasma concentrations of pro- and anti-inflammatory mediators in supernatants from whole blood stimulated with antigens ex-vivo | after 6 weeks of vitamin D3 supplementation | Cytokines, lipid mediators, stimulated blood |
| Whole blood transcriptional profiles | after 6 weeks of vitamin D3 supplementation | mRNA |
| Volumes of lung abnormalities on chest CT imaging | after 6 weeks of vitamin D3 supplementation | CT data |
| Pneumonia symptom scores | after 6 weeks of vitamin D3 supplementation | CAP-Sym scores |
| Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples | after 6 weeks of vitamin D3 supplementation | Cytokines, lipid mediators, induced sputum |
Countries
United Kingdom
Outcome results
None listed