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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 29, 2014