Recurrent Calcic Urolithiasis
Conditions
Keywords
Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi
Brief summary
The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
Interventions
DIETARY_SUPPLEMENTRenalof
One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
DIETARY_SUPPLEMENTPlacebo
One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic calcic lithiasis * Calculus size lesser than or equal to 2.0 cm (0.79 inches) * Signed informed consent
Exclusion criteria
* Calculus size greater than 2,0 cm (0.79 inches) * Pregnancy * Malignant neoplastic conditions * Previous treatment for destruction of calculi in the urinary tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment) | 12 weeks |
| Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment | 12 weeks |
| Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Oxaluria at week 12 | 12 weeks |
| Citraturia at week 12 | 12 weeks |
| Phosphatemia at week 12 | 12 weeks |
| Calcemia at week 12 | 12 weeks |
| Total plasmatic calcium at week 12 | 12 weeks |
| Calciuria at week 12 | 12 weeks |
| Calcium Oxalate crystallization risk at week 12 | 12 weeks |
| Calcium phosphate activity product at week 12 | 12 weeks |
| Calcium Oxalate activity product at week 12 | 12 weeks |
| pH of urine at week 12 | 12 weeks |
| Presence of adverse effects at any moment of treatment | 12 weeks |
| Blood ionic calcium at week 12 | 12 weeks |
| Uricosuria at week 12 | 12 weeks |
| Blood Uric acid at week 12 | 12 weeks |
Countries
Cuba
Outcome results
None listed