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

NCT ID: NCT00852020

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-04-30

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).

Conditions

Cachexia; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: EXPERIMENTAL

oral nutrition supplement, food for special medical purposes

Intervention Type: DIETARY_SUPPLEMENT

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

2

oral nutritional supplement (isocaloric, isonitrogenous)

Group Type: PLACEBO_COMPARATOR

oral nutrition supplement, food for special medical purposes

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

oral nutrition supplement, food for special medical purposes

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Anker, Prof. MD PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, , Germany

Praxis für Pneumologie, Schwedt/Oder

Schwedt, , Germany

Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED

Piekary Śląskie, , Poland

Specjalista Chorób Wewnętrznych Kardiolog

Ruda Śląska, , Poland

Countries

Germany; Poland

Other Identifiers

PCSU-002-CFS

Identifier Type: -

Identifier Source: org_study_id