LOSALT01: Low Salt Diet in Idiopathic Hypercalciuria

• Sponsor: University of Parma (Other)
• Overall Status: Completed
• CT.gov ID: NCT01005082
• Collaborator: Università Vita-Salute San Raffaele (Other), University of Milan (Other), Catholic University of the Sacred Heart (Other)
• Enrollment: 210
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypercalciuria	Behavioral: Low salt diet; Behavioral: Water therapy alone	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low salt diet plus water therapy	Behavioral: Low salt diet
Active Comparator: water therapy alone	Behavioral: Water therapy alone

Outcome Measures

Primary Outcome Measures

1. Normalization of urinary calcium levels []

Secondary Outcome Measures

1. Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Parma		Italy	43100

Sponsors and Collaborators

• University of Parma
• Università Vita-Salute San Raffaele
• University of Milan
• Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01005082
• Other Study ID Numbers: PRIN2002062925
• First Posted: Oct 30, 2009
• Last Update Posted: Oct 30, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Low salt diet, idiopathic hypercalciuria, calcium stone formers; Calcium stone formers with idiopathic hypercalciuria
• Additional relevant MeSH terms: Hypercalciuria

Study Results

No Results Posted as of Oct 30, 2009