Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03774953
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2018-12-11
Brief Title:
The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
A Randomized Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPprotein
Brief Summary:
The purpose of this clinical trial is to reduce the patients 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
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 bodys 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
This is a threat for the patients due to the fact that there is a higher risk of complications and readmissions
Proteins are the bodys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None