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

Pneumonia Clinical Trial

— ResolveD-CAP  

Official title:

A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802722
• Other study ID #: 011280
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2024
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pneumonia

Intervention

Dietary Supplement:
• Vitamin D3 supplementation
Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.

Biological:
• Peripheral blood and induced sputum sampling
To attain samples for immunological testing

Radiation:
• Chest computerised tomography (CT) scans
For volumetric quantification of lung abnormalities

Other:
• Symptom questionnaire
Symptom questionnaire for recent symptom history
• Placebo
To be dispensed using an electronic dispenser to allow real time logging of adherence.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma IL-6 concentrations	IL-6	after 6 weeks of vitamin D3 supplementation
Secondary	Serum CRP	CRP	after 6 weeks of vitamin D3 supplementation
Secondary	Total white cell count and differential white cell count in induced sputum samples	WBC and differential counts	after 6 weeks of vitamin D3 supplementation
Secondary	Immune cell phenotypes in peripheral blood	flow cytometry phenotypes, blood	after 6 weeks of vitamin D3 supplementation
Secondary	Immune cell phenotypes in induced sputum samples	flow cytometry phenotypes, induced sputum	after 6 weeks of vitamin D3 supplementation
Secondary	Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood	Cytokines, lipid mediators, blood	after 6 weeks of vitamin D3 supplementation
Secondary	Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples	Cytokines, lipid mediators, induced sputum	after 6 weeks of vitamin D3 supplementation
Secondary	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
Secondary	Whole blood transcriptional profiles	mRNA	after 6 weeks of vitamin D3 supplementation
Secondary	Volumes of lung abnormalities on chest CT imaging	CT data	after 6 weeks of vitamin D3 supplementation
Secondary	Pneumonia symptom scores	CAP-Sym scores	after 6 weeks of vitamin D3 supplementation