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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Queen Mary University of London

Current Primary Outcome: Plasma IL-6 concentrations [ Time Frame: after 6 weeks of vitamin D3 supplementation ]

IL-6


Original Primary Outcome: Plasma IL-6 concentrations [ Time Frame: after 6 weeks of vitamin D3 supplementation ]

Current Secondary Outcome:

  • Serum CRP [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CRP
  • Total white cell count and differential white cell count in induced sputum samples [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    WBC and differential counts
  • Immune cell phenotypes in peripheral blood [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    flow cytometry phenotypes, blood
  • Immune cell phenotypes in induced sputum samples [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    flow cytometry phenotypes, induced sputum
  • Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    Cytokines, lipid mediators, blood
  • Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    Cytokines, lipid mediators, induced sputum
  • Plasma concentrations of pro- and anti-inflammatory mediators in supernatants from whole blood stimulated with antigens ex-vivo [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    Cytokines, lipid mediators, stimulated blood
  • Whole blood transcriptional profiles [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    mRNA
  • Volumes of lung abnormalities on chest CT imaging [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CT data
  • Pneumonia symptom scores [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CAP-Sym scores


Original Secondary Outcome:

Information By: Queen Mary University of London

Dates:
Date Received: June 13, 2016
Date Started: February 24, 2017
Date Completion: December 2018
Last Updated: March 31, 2017
Last Verified: June 2016