NCT02802722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 24, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

June 13, 2016

Last Update Submit

April 18, 2024

Conditions

Pneumonia

Keywords

convalescenceinflammationresolutionvitamin D

Outcome Measures

Primary Outcomes (1)

  • Plasma IL-6 concentrations

    IL-6

    after 6 weeks of vitamin D3 supplementation

Secondary Outcomes (10)

  • Serum CRP

    after 6 weeks of vitamin D3 supplementation

  • Total white cell count and differential white cell count in induced sputum samples

    after 6 weeks of vitamin D3 supplementation

  • Immune cell phenotypes in peripheral blood

    after 6 weeks of vitamin D3 supplementation

  • Immune cell phenotypes in induced sputum samples

    after 6 weeks of vitamin D3 supplementation

  • Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood

    after 6 weeks of vitamin D3 supplementation

  • +5 more secondary outcomes

Study Arms (2)

Immediate supplementation

ACTIVE COMPARATOR

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 supplementationBiological: Peripheral blood and induced sputum samplingRadiation: Chest computerised tomography (CT) scansOther: Symptom questionnaire

Delayed supplementation

PLACEBO COMPARATOR

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 samplingRadiation: Chest computerised tomography (CT) scansOther: Symptom questionnaireOther: Placebo

Interventions

Vitamin D3 supplementationDIETARY_SUPPLEMENT

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

Also known as: cholecalciferol, colecalciferol
Immediate supplementation
Peripheral blood and induced sputum samplingBIOLOGICAL

To attain samples for immunological testing

Delayed supplementationImmediate supplementation
Chest computerised tomography (CT) scansRADIATION

For volumetric quantification of lung abnormalities

Delayed supplementationImmediate supplementation
Symptom questionnaireOTHER

Symptom questionnaire for recent symptom history

Delayed supplementationImmediate supplementation
PlaceboOTHER

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

Delayed supplementation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 18369199BACKGROUND

  • 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.

    PMID: 22942205BACKGROUND

MeSH Terms

Conditions

PneumoniaConvalescenceInflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Adrian Martineau, MBBS

    Queen Mary University of London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

February 24, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)