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The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia (CAPprotein)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774953
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nordsjaellands Hospital

Brief 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 for the patients.

The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Dietary Supplement: Protein and vitamin supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized to intervention or control arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
protein and vitamin supplementation
Dietary Supplement: Protein and vitamin supplementation
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

No Intervention: Control group
No supplementations



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Loss of Body weight [ Time Frame: Change from Baseline weight until 2 months after discharged ]
    Loss of body weight measured by weight scale

  2. Readmissions [ Time Frame: Up to 6 months ]
    Number of readmissions

  3. Length of hospital stay between the two groups [ Time Frame: From admission until discharge (an average of 5 days) ]
    Number of days

  4. 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 ]
    Quality of life measured by units on a scale

  5. Normal daily living function [ Time Frame: Change in physical condition from Baseline until 2 months after discharged ]
    Normal daily living function measured by units on a scale



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients with community acquired pneumonia
  • >60 years
  • Patients who are able to speak and understand Danish

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774953


Locations
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Denmark
Nordsjaellands hospital
Hillerød, Denmark
Sponsors and Collaborators
Nordsjaellands Hospital
Investigators
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Study Director: Birgitte Lindegaard Madsen Nordsjaellands Hospital
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT03774953    
Other Study ID Numbers: CAP protein
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordsjaellands Hospital:
pneumonia
community acquired pneumonia
protein
lean body mass
weight loss
readmission
infection
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs