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Low Salt Diet in Idiopathic Hypercalciuria (LOSALT01)

Primary Purpose

Hypercalciuria

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Low salt diet
Water therapy alone
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercalciuria focused on measuring Low salt diet, idiopathic hypercalciuria, calcium stone formers, Calcium stone formers with idiopathic hypercalciuria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low salt diet plus water therapy

water therapy alone

Arm Description

Outcomes

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

Full Information

First Posted
October 29, 2009
Last Updated
October 29, 2009
Sponsor
University of Parma
Collaborators
Università Vita-Salute San Raffaele, University of Milan, Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01005082
Brief Title
Low Salt Diet in Idiopathic Hypercalciuria
Acronym
LOSALT01
Official Title
Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Parma
Collaborators
Università Vita-Salute San Raffaele, University of Milan, Catholic University of the Sacred Heart

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercalciuria
Keywords
Low salt diet, idiopathic hypercalciuria, calcium stone formers, Calcium stone formers with idiopathic hypercalciuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low salt diet plus water therapy
Arm Type
Experimental
Arm Title
water therapy alone
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Low salt diet
Intervention Type
Behavioral
Intervention Name(s)
Water therapy alone
Primary Outcome Measure Information:
Title
Normalization of urinary calcium levels
Secondary Outcome Measure Information:
Title
Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Parma
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
11784873
Citation
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. doi: 10.1056/NEJMoa010369.
Results Reference
background
PubMed Identifier
20042524
Citation
Nouvenne A, Meschi T, Prati B, Guerra A, Allegri F, Vezzoli G, Soldati L, Gambaro G, Maggiore U, Borghi L. Effects of a low-salt diet on idiopathic hypercalciuria in calcium-oxalate stone formers: a 3-mo randomized controlled trial. Am J Clin Nutr. 2010 Mar;91(3):565-70. doi: 10.3945/ajcn.2009.28614. Epub 2009 Dec 30.
Results Reference
derived

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Low Salt Diet in Idiopathic Hypercalciuria

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