Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis

Conditions
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Recurrent Calcic Urolithiasis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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>Renalof | Dietary Supplement: Renalof<br>* One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks<br>|
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calciuria at week 12 |  | 12 weeks | 
| Uricosuria at week 12 |  | 12 weeks | 
| Blood Uric acid at week 12 |  | 12 weeks | 
| 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 | 
| Blood ionic calcium 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi