Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
210 participants
INTERVENTIONAL
2005-01-31
2008-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low salt diet plus water therapy
Low salt diet
water therapy alone
Water therapy alone
Interventions
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Low salt diet
Water therapy alone
Eligibility Criteria
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Inclusion Criteria
* 18-65 years.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Università Vita-Salute San Raffaele
OTHER
University of Milan
OTHER
Catholic University of the Sacred Heart
OTHER
University of Parma
OTHER
Responsible Party
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University of Parma
Locations
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University Hospital
Parma, , Italy
Countries
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References
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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. doi: 10.1056/NEJMoa010369.
Nouvenne A, Meschi T, Prati B, Guerra A, Allegri F, Vezzoli G, Soldati L, Gambaro G, Maggiore U, Borghi L. Effects of a low-salt diet on idiopathic hypercalciuria in calcium-oxalate stone formers: a 3-mo randomized controlled trial. Am J Clin Nutr. 2010 Mar;91(3):565-70. doi: 10.3945/ajcn.2009.28614. Epub 2009 Dec 30.
Other Identifiers
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PRIN2002062925
Identifier Type: -
Identifier Source: org_study_id