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

April 18, 2024 updated by: Queen Mary University of London

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma IL-6 concentrations
Time Frame: after 6 weeks of vitamin D3 supplementation
IL-6
after 6 weeks of vitamin D3 supplementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum CRP
Time Frame: after 6 weeks of vitamin D3 supplementation
CRP
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
WBC and differential counts
after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in peripheral blood
Time Frame: after 6 weeks of vitamin D3 supplementation
flow cytometry phenotypes, blood
after 6 weeks of vitamin D3 supplementation
Immune cell phenotypes in induced sputum samples
Time Frame: after 6 weeks of vitamin D3 supplementation
flow cytometry phenotypes, induced sputum
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
Cytokines, lipid mediators, blood
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
Cytokines, lipid mediators, induced sputum
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
Cytokines, lipid mediators, stimulated blood
after 6 weeks of vitamin D3 supplementation
Whole blood transcriptional profiles
Time Frame: after 6 weeks of vitamin D3 supplementation
mRNA
after 6 weeks of vitamin D3 supplementation
Volumes of lung abnormalities on chest CT imaging
Time Frame: after 6 weeks of vitamin D3 supplementation
CT data
after 6 weeks of vitamin D3 supplementation
Pneumonia symptom scores
Time Frame: after 6 weeks of vitamin D3 supplementation
CAP-Sym scores
after 6 weeks of vitamin D3 supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Mary University of London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adrian Martineau, MBBS, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 011280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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