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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01005082
Other study ID # PRIN2002062925
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 29, 2009
Last updated October 29, 2009
Start date January 2005
Est. completion date December 2008

Study information

Verified date October 2009
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Low salt diet

Water therapy alone


Locations

Country Name City State
Italy University Hospital Parma

Sponsors (4)

Lead Sponsor Collaborator
University of Parma Catholic University of the Sacred Heart, Università Vita-Salute San Raffaele, University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

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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