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Does Vitamin D Supplementation Enhance Resolution of Inflammation After Community-acquired Pneumonia? (ResolveD-CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802722
Recruitment Status : Unknown
Verified June 2016 by Queen Mary University of London.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pneumonia Dietary Supplement: Vitamin D3 supplementation Biological: Peripheral blood and induced sputum sampling Radiation: Chest computerised tomography (CT) scans Other: Symptom questionnaire Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following Community-acquired Pneumonia
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Vitamin D

Arm Intervention/treatment
Active Comparator: Immediate 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
Dietary Supplement: Vitamin D3 supplementation
Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.
Other Names:
  • cholecalciferol
  • colecalciferol

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 Comparator: Delayed supplementation
Placebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire
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

Other: Placebo
To be dispensed using an electronic dispenser to allow real time logging of adherence.




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


Secondary Outcome Measures :
  1. Serum CRP [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CRP

  2. 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

  3. Immune cell phenotypes in peripheral blood [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    flow cytometry phenotypes, blood

  4. Immune cell phenotypes in induced sputum samples [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    flow cytometry phenotypes, induced sputum

  5. Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    Cytokines, lipid mediators, blood

  6. 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

  7. 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

  8. Whole blood transcriptional profiles [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    mRNA

  9. Volumes of lung abnormalities on chest CT imaging [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CT data

  10. Pneumonia symptom scores [ Time Frame: after 6 weeks of vitamin D3 supplementation ]
    CAP-Sym scores



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802722


Contacts
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Contact: Alicia D Yeap, MBBS (44)7810715924 a.d.yeap@qmul.ac.uk

Locations
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United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: Alicia Yeap, MBBS    +447810715924    a.d.yeap@qmul.ac.uk   
Principal Investigator: Alicia Yeap, MBBS         
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Study Chair: Adrian Martineau, MBBS Queen Mary University of London
Publications:
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02802722    
Other Study ID Numbers: 011280
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Queen Mary University of London:
convalescence
inflammation
resolution
vitamin D
Additional relevant MeSH terms:
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Pneumonia
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents