PneumoniaResolveD-CAPNCT02802722
Does Vitamin D Supplementation Enhance Resolution of Inflammation After Community-acquired Pneumonia?
A study testing Vitamin D3 supplementation, Peripheral blood and induced sputum sampling and Chest computerised tomography (CT) scans in people with Pneumonia, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Vitamin D3 supplementation, Peripheral blood and induced sputum sampling and Chest computerised tomography (CT) scans
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following 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.
- Conditions
- Pneumonia
- Being tested
- Vitamin D3 supplementation, Peripheral blood and induced sputum sampling, Chest computerised tomography (CT) scans, Symptom questionnaire, Placebo
- Keywords
- convalescence, inflammation, resolution, vitamin D
- Medical subject headings
- Pneumonia, Convalescence, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 supplementationDietary supplement
Also called cholecalciferol, colecalciferol
Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.
Peripheral blood and induced sputum samplingBiological
To attain samples for immunological testing
Chest computerised tomography (CT) scansRadiation
For volumetric quantification of lung abnormalities
Symptom questionnaireOther
Symptom questionnaire for recent symptom history
PlaceboOther
To be dispensed using an electronic dispenser to allow real time logging of adherence.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Vitamin D3 supplementation; Biological: Peripheral blood and induced sputum sampling; Radiation: Chest computerised tomography (CT) scans; Other: 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 Receives: Biological: Peripheral blood and induced sputum sampling; Radiation: Chest computerised tomography (CT) scans; Other: Symptom questionnaire; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma IL-6 concentrations
IL-6
Measured: after 6 weeks of vitamin D3 supplementation
Secondary outcomes (10)
Serum CRP
CRP
Measured: after 6 weeks of vitamin D3 supplementation
Total white cell count and differential white cell count in induced sputum samples
WBC and differential counts
Measured: after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in peripheral blood
flow cytometry phenotypes, blood
Measured: after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in induced sputum samples
flow cytometry phenotypes, induced sputum
Measured: after 6 weeks of vitamin D3 supplementation
Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood
Cytokines, lipid mediators, blood
Measured: after 6 weeks of vitamin D3 supplementation
Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples
Cytokines, lipid mediators, induced sputum
Measured: after 6 weeks of vitamin D3 supplementation
Plasma concentrations of pro- and anti-inflammatory mediators in supernatants from whole blood stimulated with antigens ex-vivo
Cytokines, lipid mediators, stimulated blood
Measured: after 6 weeks of vitamin D3 supplementation
Whole blood transcriptional profiles
mRNA
Measured: after 6 weeks of vitamin D3 supplementation
Volumes of lung abnormalities on chest CT imaging
CT data
Measured: after 6 weeks of vitamin D3 supplementation
Pneumonia symptom scores
CAP-Sym scores
Measured: after 6 weeks of vitamin D3 supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start24 Feb 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Martineau, MBBS, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802722
- Sponsor's protocol ID
- 011280
- Acronym
- ResolveD-CAP
- Status last verified
- Apr 2024
- First submitted
- 13 Jun 2016
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18369199Remmelts 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.
PubMed 22942205
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02802722
- Acronym / sponsor ID
- ResolveD-CAP / 011280
- Conditions
- Pneumonia
- Keywords
- convalescence, inflammation, resolution, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate supplementation | Active comparator | Dietary Supplement: Vitamin D3 supplementation, Biological: Peripheral blood and induced sputum sampling, Radiation: Chest computerised tomography (CT) scans, Other: Symptom questionnaireDietary 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 |
| Delayed supplementation | Placebo comparator | Biological: Peripheral blood and induced sputum sampling, Radiation: Chest computerised tomography (CT) scans, Other: Symptom questionnaire, Other: PlaceboPlacebo: oral placebo capsules once daily for 6 weeks Peripheral blood and induced sputum sampling Chest computerised tomography (CT) scans Symptom questionnaire |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 supplementationAlso: cholecalciferol, colecalciferolCapsules to be dispensed using an electronic dispenser to allow real time logging of adherence. | Dietary supplement | Immediate supplementation |
| Peripheral blood and induced sputum samplingTo attain samples for immunological testing | Biological | Delayed supplementation, Immediate supplementation |
| Chest computerised tomography (CT) scansFor volumetric quantification of lung abnormalities | Radiation | Delayed supplementation, Immediate supplementation |
| Symptom questionnaireSymptom questionnaire for recent symptom history | Other | Delayed supplementation, Immediate supplementation |
| PlaceboTo be dispensed using an electronic dispenser to allow real time logging of adherence. | Other | Delayed supplementation |
Primary outcome
Plasma IL-6 concentrations
Time frame: after 6 weeks of vitamin D3 supplementation
IL-6
10 secondary outcomes
Serum CRP
Time frame: after 6 weeks of vitamin D3 supplementation
Total white cell count and differential white cell count in induced sputum samples
Time frame: after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in peripheral blood
Time frame: after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in induced sputum samples
Time frame: after 6 weeks of vitamin D3 supplementation
Plasma concentrations of pro- and anti-inflammatory mediators in peripheral blood
Time frame: after 6 weeks of vitamin D3 supplementation
Plasma concentrations of pro- and anti-inflammatory mediators in induced sputum samples
Time frame: after 6 weeks of vitamin D3 supplementation
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
Whole blood transcriptional profiles
Time frame: after 6 weeks of vitamin D3 supplementation
Volumes of lung abnormalities on chest CT imaging
Time frame: after 6 weeks of vitamin D3 supplementation
Pneumonia symptom scores
Time frame: after 6 weeks of vitamin D3 supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 18369199Yende 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.
- Background: PubMed 22942205Remmelts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Martineau, MBBS study chair
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 supplementation, Peripheral blood and induced sputum sampling and Chest computerised tomography (CT) scans in people with Pneumonia, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma IL-6 concentrations (time frame: after 6 weeks of vitamin D3 supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.