Malnutrition in Gastroenterology Patients

May 6, 2010 updated by: Charite University, Berlin, Germany

Background: Malnutrition is frequently occurring in sick patients and is associated with a higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which leads to a reduced functional status and quality of life.

Specific aims: The purpose of the study is to evaluate the effect of a three month nutritional intervention with oral supplements on nutritional status, muscle function and quality of life.

Study Overview

Status

Completed

Conditions

Malnutrition

Intervention / Treatment

Drug: Fresubin protein energy Drink (CAVE! nutritional intervention)

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

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

Study Locations

Germany
- - Berlin, Germany, 10117
    - Charite Universitätsmedizin Berlin CCm

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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Malnutrition
Benign disease

Exclusion Criteria:

Malignant disease

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

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

Principal Investigator: Matthias Pirlich, MD, Charite Universitätsmedizin Berlin ,Klinik für Gastroenterologie CCM

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

Norman K, Pirlich M, Smoliner C, Kilbert A, Schulzke JD, Ockenga J, Lochs H, Reinhold T. Cost-effectiveness of a 3-month intervention with oral nutritional supplements in disease-related malnutrition: a randomised controlled pilot study. Eur J Clin Nutr. 2011 Jun;65(6):735-42. doi: 10.1038/ejcn.2011.31. Epub 2011 Mar 16.

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

March 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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.