Low Salt Diet in Idiopathic Hypercalciuria (LOSALT01)

University of Parma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypercalciuria

Treatments: Behavioral: Water therapy alone; Behavioral: Low salt diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01005082

PRIN2002062925

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Low salt diet plus water therapy

Experimental group

Treatment:

Behavioral: Low salt diet

water therapy alone

Active Comparator group

Treatment:

Behavioral: Water therapy alone