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Low Salt Diet in Idiopathic Hypercalciuria (LOSALT01)

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ClinicalTrials.gov Identifier: NCT01005082
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : October 30, 2009
Sponsor:
Collaborators:
Università Vita-Salute San Raffaele
University of Milan
Catholic University of the Sacred Heart
Information provided by:
University of Parma

Tracking Information
First Submitted Date  ICMJE October 29, 2009
First Posted Date  ICMJE October 30, 2009
Last Update Posted Date October 30, 2009
Study Start Date  ICMJE January 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Normalization of urinary calcium levels
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Salt Diet in Idiopathic Hypercalciuria
Official Title  ICMJE Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercalciuria
Intervention  ICMJE
  • Behavioral: Low salt diet
  • Behavioral: Water therapy alone
Study Arms  ICMJE
  • Experimental: Low salt diet plus water therapy
    Intervention: Behavioral: Low salt diet
  • Active Comparator: water therapy alone
    Intervention: Behavioral: Water therapy alone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
210
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005082
Other Study ID Numbers  ICMJE PRIN2002062925
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Parma
Study Sponsor  ICMJE University of Parma
Collaborators  ICMJE
  • Università Vita-Salute San Raffaele
  • University of Milan
  • Catholic University of the Sacred Heart
Investigators  ICMJE Not Provided
PRS Account University of Parma
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP