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Low Salt Diet in Idiopathic Hypercalciuria

NCT01005082 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2009-10-30

No results posted yet for this study

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

Conditions

  • Hypercalciuria

Interventions

BEHAVIORAL

Low salt diet

BEHAVIORAL

Water therapy alone

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • University of Parma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005082 on ClinicalTrials.gov