Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients

This study has been completed.

Sponsor:

Information provided by:

Fresenius Kabi

ClinicalTrials.gov Identifier:

NCT00852020

First received: February 13, 2009

Last updated: June 1, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 13, 2009

Last Updated Date

June 1, 2011

Start Date ^ICMJE

April 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

compliance to nutrition therapy [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00852020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

anorexia questionnaire [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
Gastrointestinal syndrome score (GIS) [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
body cell mass [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
weight change [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
hand grip strength [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
patient global assessment (PGA) [ Time Frame: baseline, months 2, 4 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients

Official Title ^ICMJE

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.

Brief Summary

To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Cachexia
Chronic Obstructive Pulmonary Disease
Chronic Heart Failure

Intervention ^ICMJE

Dietary Supplement: oral nutrition supplement, food for special medical purposes

2 servings of 200-300 ml per day, treatment period: 16 weeks

Study Arm (s)

Experimental: 1
oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants

Intervention: Dietary Supplement: oral nutrition supplement, food for special medical purposes
Placebo Comparator: 2
oral nutritional supplement (isocaloric, isonitrogenous)

Intervention: Dietary Supplement: oral nutrition supplement, food for special medical purposes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

diagnosis of CHF or COPD
current body weight less than 6 months ago
BMI >=20 and <=30 kg/m2
CHF: LVEF >=45% measured within the past 6 months
symptom status equivalent to NYHA class II to IV
biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
on standard therapy of CHF including ACE inhibitors and beta blockers
COPD: symptom status equivalent to GOLD standard class II to IV
FEV1 < 80%
FEV1/FEV < 70%

Exclusion Criteria:

significant oedema in the time of screening and randomisation
concomitant inflammatory diseases
active infections including HIV and AIDS
liver failure
chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker
acute or chronic infections
insulin treated diabetes mellitus
patient with established diagnosis of cachexia
life expectancy of less than 6 months in the opinion of the investigator
medications that impair sex hormone synthesis, secretion or function
patients with psychiatric diseases
body weight loss > 5% during the last 6 months or > 10% during the last 10 months
suspected allergy to any component of the investigational product(s)
fish oil supplementation within 3 months prior to the study entry
taking vitamin supplements in doses greater than the Recommended Daily Allowances

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Poland

Administrative Information

NCT Number ^ICMJE

NCT00852020

Other Study ID Numbers ^ICMJE

PCSU-002-CFS

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Ericka Pestana, I&D Clinical Nutrition & Pharmaceuticals, SP&T, Fresenius Kabi Deutschland GmbH

Study Sponsor ^ICMJE

Fresenius Kabi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefan Anker, Prof. MD PHD

Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin

Information Provided By

Fresenius Kabi

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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