NCT02802722CompletedNot Applicable
A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following Community-acquired Pneumonia
Queen Mary University of London2 sites in 1 country3 target enrollmentStarted: February 24, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Plasma IL-6 concentrations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults ≥50 years of age
- •Vitamin D deficiency at entry, defined as a serum total 25(OH)D concentration <50 nmol/L
- •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
- •Adequate mental capacity to give informed consent for participation in the study and gives written informed consent
Exclusion Criteria
- •Currently taking any vitamin D supplementation
- •Known HIV infection, other condition causing immunosuppression, current immunosuppressive therapy or systemic corticosteroids
- •Known malignancy not in remission for >3 years or terminal illness with prognosis <1year
- •History of smoking within the previous 1 year
- •Known or suspected diagnosis of chronic obstructive pulmonary disease (COPD)
- •Previous hospitalisation within 10 days of admission
- •Aspiration pneumonia diagnosed by the clinical team
- •Known diagnosis of cystic fibrosis, bronchiectasis or interstitial lung disease at screening
- •Complications of pneumonia such as empyema or lung abscess at entry
- •Recent acute coronary syndrome within the previous 1 month
- •Long term oxygen therapy, chronic mechanical ventilation dependency or other contraindication to sputum induction
- •Serum corrected calcium concentration >2.65 mmol/L at entry
- •Chronic kidney disease stage 4-5 (estimated glomerular filtration rate <30ml/min) on an existing blood sample from the current hospital admission
- •Known clinical diagnosis of liver failure
- •Known or suspected diagnosis of active pulmonary tuberculosis
- •Known diagnosis of primary hyperparathyroidism
- •Known diagnosis of sarcoidosis
- •Known diagnosis of nephrolithiasis
- •Taking carbamazepine, phenytoin, phenobarbital, primidone, cardiac glycosides or benzothiadiazines with concomitant calcium supplementation at entry
- •Known allergy to vitamin D or its excipients
- •Currently taking part in another research study
Outcomes
Primary Outcomes
Plasma IL-6 concentrations
Time Frame: after 6 weeks of vitamin D3 supplementation
IL-6
Secondary Outcomes
- Immune cell phenotypes in induced sputum samples(after 6 weeks of vitamin D3 supplementation)
- Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood(after 6 weeks of vitamin D3 supplementation)
- Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples(after 6 weeks of vitamin D3 supplementation)
- Total white cell count and differential white cell count in induced sputum samples(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(after 6 weeks of vitamin D3 supplementation)
- Whole blood transcriptional profiles(after 6 weeks of vitamin D3 supplementation)
- Pneumonia symptom scores(after 6 weeks of vitamin D3 supplementation)
- Immune cell phenotypes in peripheral blood(after 6 weeks of vitamin D3 supplementation)
- Volumes of lung abnormalities on chest CT imaging(after 6 weeks of vitamin D3 supplementation)
- Serum CRP(after 6 weeks of vitamin D3 supplementation)
Investigators
Study Sites (2)
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