Hypercalciuria Clinical Trial
— LOSALT01Official title:
Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
Verified date | October 2009 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone
in patients affected by idiopathic calcium nephrolithiasis.
Treatment duration: three months Primary end-point: correction of hypercalciuria Main
inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one
stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300
mg/day in males and >200 mg/day in females); 18-65 years.
Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric
hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis,
sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D,
acetazolamide, anti-epileptic drugs
Status | Completed |
Enrollment | 210 |
Est. completion date | December 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Main inclusion criteria: - idiopathic calcium stone formers, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300 mg/day in males and 20 mg/day in females); - 18-65 years. Main exclusion criteria: - primary hyperparathyroidism, - primary hyperoxaluria, - enteric hyperoxaluria, - bowel resection, - inflammatory bowel disease, - renal tubular acidosis, - sarcoidosis, sponge kidney, - hyperthyroidism, - use of hypercalciuric drugs such as Vitamin D, - acetazolamide, - anti-epileptic drugs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital | Parma |
Lead Sponsor | Collaborator |
---|---|
University of Parma | Catholic University of the Sacred Heart, Università Vita-Salute San Raffaele, University of Milan |
Italy,
Borghi L, Schianchi T, Meschi T, Guerra A, Allegri F, Maggiore U, Novarini A. Comparison of two diets for the prevention of recurrent stones in idiopathic hypercalciuria. N Engl J Med. 2002 Jan 10;346(2):77-84. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normalization of urinary calcium levels | |||
Secondary | Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction |
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