Low Salt Diet in Idiopathic Hypercalciuria

Phase 2

Completed

• Conditions: Hypercalciuria

• Registration Number: NCT01005082
• Lead Sponsor: University of Parma

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2009-10
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Last Update Submitted: 2009-10-29
• Study First Posted: 2009-10-30
• Last Update Posted: 2009-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Normalization of urinary calcium levels

Secondary Outcome Measures

Name	Time	Method
Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Parma, Italy