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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852020
• Other study ID #: PCSU-002-CFS
• Status: Completed
• Phase: N/A
• First received: February 13, 2009
• Last updated: January 30, 2017
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2017
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Chronic Heart Failure
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• oral nutrition supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks

Locations

Country	Name	City	State
Germany	Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum	Berlin
Germany	Praxis für Pneumologie, Schwedt/Oder	Schwedt/Oder
Poland	Regionalne Centrum Leczenia Chorób Pluc i Alergii, NZOZ ALLMED	Piekary Slaskie
Poland	Specjalista Chorób Wewnetrznych Kardiolog	Ruda Slaska

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance to nutrition therapy		baseline, months 1, 2, 3, 4
Secondary	anorexia questionnaire		baseline, months 1, 2, 3, 4
Secondary	Gastrointestinal syndrome score (GIS)		baseline, months 1, 2, 3, 4
Secondary	body cell mass		baseline, months 1, 2, 3, 4
Secondary	weight change		baseline, months 1, 2, 3, 4
Secondary	hand grip strength		baseline, months 1, 2, 3, 4
Secondary	patient global assessment (PGA)		baseline, months 2, 4