Community-acquired PneumoniaCAPproteinNCT03774953
The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia
A study testing Protein and vitamin supplementation in people with Community-acquired Pneumonia, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Protein and vitamin supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2019to 30 Jun 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with community acquired pneumonia
- >60 years
- Patients who are able to speak and understand Danish
Who cannot join
- Patients with hospitalized acquired pneumonia
- Patients with septic shock
- Patients with an active cancer and in cancer treatment
- Patients in dialysis
- ICU patients
- Patients unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients.
The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.
Read the detailed description
Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue.
This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions.
Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients.
Methods:
Inclusion: 40 men and women >60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Protein and vitamin supplementation
- Keywords
- pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Weight Loss, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein and vitamin supplementationDietary supplement
The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | protein and vitamin supplementation Receives: Dietary Supplement: Protein and vitamin supplementation |
| Control group | No intervention | No supplementations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Lean Body Mass
Loss of lean body mass measured by bioimpedance
Measured: Change from Baseline lean body mass until 2 months after discharged
Secondary outcomes (5)
Loss of Body weight
Loss of body weight measured by weight scale
Measured: Change from Baseline weight until 2 months after discharged
Readmissions
Number of readmissions
Measured: Up to 6 months
Length of hospital stay between the two groups
Number of days
Measured: From admission until discharge (an average of 5 days)
Quality of life measured by units on a scale
Quality of life measured by units on a scale
Measured: Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
Normal daily living function
Normal daily living function measured by units on a scale
Measured: Change in physical condition from Baseline until 2 months after discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start15 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to intervention or control arm
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgitte Lindegaard Madsen, Study director, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774953
- Sponsor's protocol ID
- CAP protein
- Acronym
- CAPprotein
- Status last verified
- Aug 2019
- First submitted
- 11 Dec 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03774953
- Acronym / sponsor ID
- CAPprotein / CAP protein
- Conditions
- Community-acquired Pneumonia
- Keywords
- pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Dec 2018 (actual)
- 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.
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients.
The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.
Detailed description
Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue.
This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions.
Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients.
Methods:
Inclusion: 40 men and women >60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to intervention or control arm
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Protein and vitamin supplementationprotein and vitamin supplementation |
| Control group | No intervention | –No supplementations |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients with community acquired pneumonia
- >60 years
- Patients who are able to speak and understand Danish
Key exclusion criteria (6 listed)
- Patients with hospitalized acquired pneumonia
- Patients with septic shock
- Patients with an active cancer and in cancer treatment
- Patients in dialysis
- ICU patients
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 |
|---|---|---|
| Protein and vitamin supplementationThe intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement | Dietary supplement | Intervention group |
Primary outcome
Loss of Lean Body Mass
Time frame: Change from Baseline lean body mass until 2 months after discharged
Loss of lean body mass measured by bioimpedance
5 secondary outcomes
Loss of Body weight
Time frame: Change from Baseline weight until 2 months after discharged
Readmissions
Time frame: Up to 6 months
Length of hospital stay between the two groups
Time frame: From admission until discharge (an average of 5 days)
Quality of life measured by units on a scale
Time frame: Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
Normal daily living function
Time frame: Change in physical condition from Baseline until 2 months after discharged
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 13 Sep 2019.
Related trials for Community-acquired Pneumonia
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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.
Birgitte Lindegaard Madsen study director
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and vitamin supplementation in people with Community-acquired Pneumonia, run by Nordsjaellands Hospital at 1 site in Denmark.
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 3 inclusion and 6 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 13 Sep 2019. 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 Denmark. 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. 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?
Loss of Lean Body Mass (time frame: Change from Baseline lean body mass until 2 months after discharged). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2019.