Malnutrition in Gastroenterology Patients

NCT ID: NCT00168935

Last Updated: 2010-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Fresubin protein energy Drink (CAVE! nutritional intervention)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Malnutrition
* Benign disease

Exclusion Criteria

* Malignant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charite University Medicine

Principal Investigators

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Matthias Pirlich, MD

Role: PRINCIPAL_INVESTIGATOR

Charite Universitätsmedizin Berlin ,Klinik für Gastroenterologie CCM

Locations

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Charite Universitätsmedizin Berlin CCm

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 21407248 (View on PubMed)

Other Identifiers

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AN1

Identifier Type: -

Identifier Source: org_study_id

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