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NCT Number: NCT01005082

Low Salt Diet in Idiopathic Hypercalciuria

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

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Key information

Conditions

Hypercalciuria Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital

Parma, 43100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low salt diet

Behavioral

Water therapy alone

Behavioral

Primary outcomes

  1. Normalization of urinary calcium levels

Secondary outcomes

  1. Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • Catholic University of the Sacred Heart
  • University of Milan
  • Università Vita-Salute San Raffaele

Registry information

Official study title

Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants

Acronym: LOSALT01

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 30, 2009
Registry last updated
Oct 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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