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Completed

NCT Number: NCT02802722

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 Supplementation

Dietary Supplement

Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.

Other names: cholecalciferol, colecalciferol

Peripheral blood and induced sputum sampling

Biological

To attain samples for immunological testing

Chest computerised tomography (CT) scans

Radiation

For volumetric quantification of lung abnormalities

Symptom questionnaire

Other

Symptom questionnaire for recent symptom history

Placebo

Other

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

Primary outcomes

  1. Plasma IL-6 concentrations

    Time frame: after 6 weeks of vitamin D3 supplementation

    IL-6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: ResolveD-CAP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2016
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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