Chronic Inflammatory Syndrome
Conditions
Keywords
dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid
Brief 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.
Interventions
DIETARY_SUPPLEMENTViusid
3 Viusid bags (Orally administered) per day, for 60 weeks
DIETARY_SUPPLEMENTPlacebo
3 Placebo bags (Orally administered) per day, for 60 weeks.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Cholesterol 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 |
| Adverse effects 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 |
Countries
Cuba
Outcome results
None listed