Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Inflammatory Syndrome

Intervention / Treatment
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* Dietary Supplement: Viusid
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months Signed informed consent Exclusion Criteria: Patients with chronic terminal nephropathy previously treated with peritoneal dialysis Receptors of a renal graft Patients with malignant neoplastic conditions Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet | Dietary Supplement: Viusid<br>* 3 Viusid bags (Orally administered) per day, for 60 weeks<br>|
| Placebo Comparator: B<br>Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet | Dietary Supplement: Placebo<br>* 3 Placebo bags (Orally administered) per day, for 60 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) at week 72 (end of the treatment) |  | 72 weeks | 
| Carotidal Doppler at week 72 (end of the treatment) |  | 72 weeks | 
| C reactive protein at weeks 72 (end of the treatment) |  | 72 weeks | 
| Hemoglobin at week 72 (end of the treatment) |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol at week 72 |  | 72 weeks | 
| Triglycerides at week 72 |  | 72 weeks | 
| Frequency of infection episodes at week 72 |  | 72 weeks | 
| Creatinine at week 72 |  | 72 weeks | 
| Uric acid at week 72 |  | 72 weeks | 
| Glutamic-pyruvic transaminase (GPT)at week 72 |  | 72 weeks | 
| Glutamic-oxaloacetic transaminase (GOT)at week 72 |  | 72 weeks | 
| Blood glucose concentrations at week 72 |  | 72 weeks | 
| Gasometry at week 72 |  | 72 weeks | 
| Adverse effects at week 72 |  | 72 weeks | 
| Albumin at week 72 |  | 72 weeks | 
| KTV at week 72 |  | 72 weeks | 
| Phosphocalcic metabolism at week 72 |  | 72 weeks | 
| Hematocrit at week 72 |  | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid