HypercalciuriaPhase 2/3LOSALT01NCT01005082
Low Salt Diet in Idiopathic Hypercalciuria
A Phase 2/3 study testing Low salt diet and Water therapy alone in people with Hypercalciuria, run by University of Parma at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercalciuria
- What is being tested?
- Low salt diet and Water therapy alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
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
- Being tested
- Low salt diet, Water therapy alone
- Keywords
- Low salt diet, idiopathic hypercalciuria, calcium stone formers, Calcium stone formers with idiopathic hypercalciuria
- Medical subject headings
- Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salt dietBehavioural
Water therapy aloneBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Low salt diet plus water therapy | Experimental | Not described Receives: Behavioral: Low salt diet |
| water therapy alone | Active comparator | Not described Receives: Behavioral: Water therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2005
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercalciuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele, University of Milan, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005082
- Sponsor's protocol ID
- PRIN2002062925
- Acronym
- LOSALT01
- Status last verified
- Oct 2009
- First submitted
- 29 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
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 11784873Nouvenne 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
- ClinicalTrials.gov ID
- NCT01005082
- Acronym / sponsor ID
- LOSALT01 / PRIN2002062925
- Conditions
- Hypercalciuria
- Keywords
- Low salt diet, idiopathic hypercalciuria, calcium stone formers, Calcium stone formers with idiopathic hypercalciuria
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele, University of Milan, Catholic University of the Sacred Heart
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low salt diet plus water therapy | Experimental | Behavioral: Low salt diet |
| water therapy alone | Active comparator | Behavioral: Water therapy alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low salt diet | Behavioural | Low salt diet plus water therapy |
| Water therapy alone | Behavioural | water therapy alone |
Primary outcome
Normalization of urinary calcium levels
1 secondary outcome
Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
- Background: PubMed 11784873Borghi 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.
- Derived from this study: PubMed 20042524Nouvenne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low salt diet and Water therapy alone in people with Hypercalciuria, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of urinary calcium levels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2009.