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

February 13, 2009
June 1, 2011
April 2009
April 2011   (final data collection date for primary outcome measure)
compliance to nutrition therapy [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852020 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Cachexia
  • Chronic Obstructive Pulmonary Disease
  • Chronic Heart Failure
Dietary Supplement: oral nutrition supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland
 
NCT00852020
PCSU-002-CFS
Not Provided
Dr. Ericka Pestana, I&D Clinical Nutrition & Pharmaceuticals, SP&T, Fresenius Kabi Deutschland GmbH
Fresenius Kabi
Not Provided
Principal Investigator: Stefan Anker, Prof. MD PHD Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
Fresenius Kabi
June 2011

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