NCT00852020

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral nutrition supplement, food for special medical purposes	2 servings of 200-300 ml per day, treatment period: 16 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-02-26
• Last updated: 2017-01-31

Locations

4 sites across 2 countries: Germany, Poland