NCT03343743

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 10, 2017

Last Update Submit

November 10, 2017

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

  • Changes in renal papillary density

    Renal papillary density measured with unenhanced CT scan

    At baseline and after 12 months

Study Arms (1)

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

Other: Oligomineral water

Interventions

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

Hydration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing endourological procedures for renal stones
  • Recurrent stone disease
  • Calcium oxalate stones (\>50% of the stone made of calcium oxalate)

You may not qualify if:

  • Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
  • Non-calcium oxalate stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30419887DERIVED

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 17, 2017

Record last verified: 2017-11