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CompletedNCT00168935Updated May 7, 2010

Malnutrition in Gastroenterology Patients

A Phase 4 interventional study of Fresubin protein energy Drink (CAVE! nutritional intervention) in Malnutrition, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-05-07.

Sponsored by Charite University, Berlin, Germany · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

Browse Malnutrition studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Malnutrition
  • Benign disease

Exclusion criteria

Exclusion Criteria:

  • Malignant disease
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Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugFresubin protein energy Drink (CAVE! nutritional intervention)
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Study locations

1 site
  • Charite Universitätsmedizin Berlin CCm
    Berlin, 10117, Germany
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References and documents

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. PubMed 21407248 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00168935
Lead sponsor
Charite University, Berlin, Germany
First posted
Sep 15, 2005
Start date
Mar 2004
Primary completion
Aug 2007
Completion
Dec 2008
Last update
May 7, 2010

Study contacts

Matthias Pirlich, MD
principal investigator · Charite Universitätsmedizin Berlin ,Klinik für Gastroenterologie CCM
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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