Low Salt Diet in Idiopathic Hypercalciuria

Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005082

Acronym

LOSALT01

Enrollment

210

Registered

2009-10-30

Start date

2005-01-31

Completion date

2008-12-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercalciuria

Keywords

Low salt diet, idiopathic hypercalciuria, calcium stone formers, Calcium stone formers with idiopathic hypercalciuria

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

Interventions

BEHAVIORALLow salt diet

BEHAVIORALWater therapy alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Normalization of urinary calcium levels	—

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026