Low Salt Diet in Idiopathic Hypercalciuria (LOSALT01)

This study has been completed.
Sponsor:
Collaborators:
Università Vita-Salute San Raffaele
University of Milan
Catholic University of the Sacred Heart
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT01005082
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hypercalciuria
Behavioral: Low salt diet
Behavioral: Water therapy alone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Normalization of urinary calcium levels

Secondary Outcome Measures:
  • Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction

Enrollment: 210
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low salt diet plus water therapy Behavioral: Low salt diet
Active Comparator: water therapy alone Behavioral: Water therapy alone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005082

Locations
Italy
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Parma
ClinicalTrials.gov Identifier: NCT01005082     History of Changes
Other Study ID Numbers: PRIN2002062925
Study First Received: October 29, 2009
Last Updated: October 29, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
Low salt diet, idiopathic hypercalciuria, calcium stone formers
Calcium stone formers with idiopathic hypercalciuria

Additional relevant MeSH terms:
Hypercalciuria
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014