ClinicalTrials.gg
Sign In
CompletedNCT01005082LOSALT01Updated Oct 30, 2009

Low Salt Diet in Idiopathic Hypercalciuria

A Phase 2/3 interventional study of Low salt diet and Water therapy alone in Hypercalciuria, sponsored by University of Parma. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-10-30.

Sponsored by University of Parma · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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

02

Conditions studied

  • Hypercalciuria

Browse trials for

Keywords

  • Low salt diet, idiopathic hypercalciuria, calcium stone formers
  • Calcium stone formers with idiopathic hypercalciuria
03

In context

Hypercalciuria

33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.

This study's enrollment of 210 is above the median of 40 across 25 interventional studies indexed under Hypercalciuria.

Browse Hypercalciuria studies →

Lead sponsor

University of Parma is the lead sponsor of 77 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    Low salt diet plus water therapy

    Behavioral: Low salt diet

  • Active comparator
    water therapy alone

    Behavioral: Water therapy alone

Interventions

  • BehavioralLow salt diet
  • BehavioralWater therapy alone
06

What researchers measure

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

07

Study locations

1 site
  • University Hospital
    Parma, 43100, Italy
08

References and documents

Publications

  • 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. PubMed 11784873 ↗
  • 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. PubMed 20042524 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Sep 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2009
First posted
Oct 30, 2009
Start
Jan 2005
Primary completionActual
Sep 2008
CompletionActual
Dec 2008
Last update
Oct 30, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01005082
Lead sponsor
University of Parma
Collaborators
Università Vita-Salute San Raffaele, University of Milan, Catholic University of the Sacred Heart
First posted
Oct 30, 2009
Start date
Jan 2005
Primary completion
Sep 2008
Completion
Dec 2008
Last update
Oct 30, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercalciuria →

Other studies from this sponsor

University of Parma

Start the discussion