The Effect of Protein Supplement on Lean Body Mass in Pat... | NCT03774953

Studies
The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia

NCT03774953

Sponsor

Nordsjaellands Hospital

Status

Completed

Last Update Posted

Sep 13, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Community-acquired Pneumonia

Interventions

Protein and vitamin supplementation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2019Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Dec 11, 2018

First Submission Date that Met QC Criteria

Dec 11, 2018

First Posted Date

Dec 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2019

Last Update Posted Date

Sep 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	protein and vitamin supplementation	Dietary Supplement: Protein and vitamin supplementation
Control group	No Intervention	No supplementations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein and vitamin supplementation	Dietary 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Loss of Lean Body Mass	Loss of lean body mass measured by bioimpedance	Change from Baseline lean body mass until 2 months after discharged

Secondary Outcomes

Measure	Description	Time Frame
Loss of Body weight	Loss of body weight measured by weight scale	Change from Baseline weight until 2 months after discharged
Readmissions	Number of readmissions

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgitte Lindegaard Madsen	Nordsjaellands Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nordsjaellands hospital		Hillerød			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000098968	Community-Acquired Pneumonia
D011014	Pneumonia
D015431	Weight Loss
D007239	Infections

Ancestor Terms

ID	Term
D017714	Community-Acquired Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011506	Proteins

Ancestor Terms

ID	Term
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided