NCT00168935

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 7, 2010

Status Verified

September 1, 2005

Enrollment Period

3.4 years

First QC Date

September 13, 2005

Last Update Submit

May 6, 2010

Conditions

Malnutrition

Interventions

Fresubin protein energy Drink (CAVE! nutritional intervention)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malnutrition
  • Benign disease

You may not qualify if:

  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universitätsmedizin Berlin CCm

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21407248DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Matthias Pirlich, MD

    Charite Universitätsmedizin Berlin ,Klinik für Gastroenterologie CCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

March 1, 2004

Primary Completion

August 1, 2007

Study Completion

December 1, 2008

Last Updated

May 7, 2010

Record last verified: 2005-09

Locations

DE(1)