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
  Purpose

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).


Condition Intervention
Cachexia
Chronic Obstructive Pulmonary Disease
Chronic Heart Failure
Dietary Supplement: oral nutrition supplement, food for special medical purposes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants
Dietary Supplement: oral nutrition supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks
Placebo Comparator: 2
oral nutritional supplement (isocaloric, isonitrogenous)
Dietary Supplement: oral nutrition supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852020

Locations
Germany
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
Berlin, Germany, D-13353
Praxis für Pneumologie, Schwedt/Oder
Schwedt/Oder, Germany, D-16303
Poland
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
Piekary Śląskie, Poland, PL-41-940
Specjalista Chorób Wewnętrznych Kardiolog
Ruda Śląska, Poland, PL-41-709
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Stefan Anker, Prof. MD PHD Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
  More Information

No publications provided

Responsible Party: Dr. Ericka Pestana, I&D Clinical Nutrition & Pharmaceuticals, SP&T, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00852020     History of Changes
Other Study ID Numbers: PCSU-002-CFS
Study First Received: February 13, 2009
Last Updated: June 1, 2011
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Cachexia
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 15, 2014