Status:
COMPLETED
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
Lead Sponsor:
Fresenius Kabi
Conditions:
Cachexia
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00852020
Start Date
April 1 2009
End Date
April 1 2011
Last Update
January 31 2017
Active Locations (4)
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1
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
Berlin, Germany, D-13353
2
Praxis für Pneumologie, Schwedt/Oder
Schwedt, Germany, D-16303
3
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
Piekary Śląskie, Poland, PL-41-940
4
Specjalista Chorób Wewnętrznych Kardiolog
Ruda Śląska, Poland, PL-41-709