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Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

NCT00978224 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2010-07-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Mirna Atiés Sánchez, MD · Institute of Nephrology "Dr. Abelardo Buch López"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978224 on ClinicalTrials.gov