Does Vitamin D Supplementation Enhance Resolution of Inflammation After Community-acquired Pneumonia?

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Dietary Supplement: Vitamin D3 supplementation; Biological: Peripheral blood and induced sputum sampling; Radiation: Chest computerised tomography (CT) scans; Other: Symptom questionnaire; Other: Placebo

• Registration Number: NCT02802722
• Lead Sponsor: Queen Mary University of London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-16
• Study Start: 2017-02-24
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immediate supplementation	Peripheral blood and induced sputum sampling	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
Immediate supplementation	Chest computerised tomography (CT) scans	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
Immediate supplementation	Symptom questionnaire	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	Peripheral blood and induced sputum sampling	Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire
Delayed supplementation	Symptom questionnaire	Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire
Delayed supplementation	Placebo	Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire
Immediate supplementation	Vitamin D3 supplementation	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	Chest computerised tomography (CT) scans	Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire

Primary Outcome Measures

Name	Time	Method
Plasma IL-6 concentrations	after 6 weeks of vitamin D3 supplementation	IL-6

Secondary Outcome Measures

Name	Time	Method
Serum CRP	after 6 weeks of vitamin D3 supplementation	CRP
Pneumonia symptom scores	after 6 weeks of vitamin D3 supplementation	CAP-Sym scores
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
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 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
Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples	after 6 weeks of vitamin D3 supplementation	Cytokines, lipid mediators, induced sputum
Immune cell phenotypes in peripheral blood	after 6 weeks of vitamin D3 supplementation	flow cytometry phenotypes, blood
Volumes of lung abnormalities on chest CT imaging	after 6 weeks of vitamin D3 supplementation	CT data

Trial Locations

Locations (1)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom