NCT00978224

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.

Conditions

• Chronic Inflammatory Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Viusid	3 Viusid bags (Orally administered) per day, for 60 weeks
DIETARY_SUPPLEMENT	Placebo	3 Placebo bags (Orally administered) per day, for 60 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-09-16
• Last updated: 2010-07-07

Locations

1 site across 1 country: Cuba