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OpenTrials
Completed

NCT Number: NCT03343743

Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

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.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oligomineral water

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

Primary outcomes

  1. Changes in renal papillary density

    Time frame: At baseline and after 12 months

    Renal papillary density measured with unenhanced CT scan

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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