Malnutrition in Gastroenterology Patients

Malnutrition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168935
• Other study ID #: AN1
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 6, 2010
• Start date: March 2004
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Malnutrition

• Benign disease

Exclusion Criteria:

• Malignant disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin CCm	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany,