Low Salt Diet in Idiopathic Hypercalciuria

Hypercalciuria Clinical Trial

— LOSALT01  

Official title:

Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005082
• Other study ID #: PRIN2002062925
• 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
• 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

• Hypercalciuria

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