UrolithiasisNCT03343743
Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
A study testing Oligomineral water in people with Urolithiasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Oligomineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing endourological procedures for renal stones
- Recurrent stone disease
- Calcium oxalate stones (>50% of the stone made of calcium oxalate)
Who cannot join
- Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
- Non-calcium oxalate stones
About this study
Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.
- Conditions
- Urolithiasis
- Being tested
- Oligomineral water
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligomineral waterOther
Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months
| Study group | Role | What they receive |
|---|---|---|
| Hydration | Other | Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months Receives: Other: Oligomineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in renal papillary density
Renal papillary density measured with unenhanced CT scan
Measured: At baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343743
- Sponsor's protocol ID
- 6118/13
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferraro PM, Vittori M, Macis G, D'Addessi A, Lombardi G, Palmisano C, Gervasoni J, Primiano A, Bassi PF, Gambaro G. Changes in renal papillary density after hydration therapy in calcium stone formers. BMC Urol. 2018 Nov 12;18(1):101. doi: 10.1186/s12894-018-0415-7.
PubMed 30419887
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
- ClinicalTrials.gov ID
- NCT03343743
- Acronym / sponsor ID
- 6118/13
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydration | Other | Other: Oligomineral waterPatients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing endourological procedures for renal stones
- Recurrent stone disease
- Calcium oxalate stones (>50% of the stone made of calcium oxalate)
Key exclusion criteria (2 listed)
- Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
- Non-calcium oxalate stones
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 |
|---|---|---|
| Oligomineral waterPatients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months | Other | Hydration |
Primary outcome
Changes in renal papillary density
Time frame: At baseline and after 12 months
Renal papillary density measured with unenhanced CT scan
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 17 Nov 2017.
- Derived from this study: PubMed 30419887Ferraro PM, Vittori M, Macis G, D'Addessi A, Lombardi G, Palmisano C, Gervasoni J, Primiano A, Bassi PF, Gambaro G. Changes in renal papillary density after hydration therapy in calcium stone formers. BMC Urol. 2018 Nov 12;18(1):101. doi: 10.1186/s12894-018-0415-7.
Related trials for Urolithiasis
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
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.
Questions about this trial
What is this clinical trial studying?
A study testing Oligomineral water in people with Urolithiasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Changes in renal papillary density (time frame: At baseline and after 12 months). 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 NCT03343743, which also lists 1 linked publication.
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 17 Nov 2017.