Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Water

• Registration Number: NCT03447847
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Interventional crossover study on healthy volunteers aimed at evaluating the effect of the composition and timing of ingestion of different types of water on the urinary excretion of lithogenic substances; the study will also analyze the effect of potassium citrate on urine pH and lithogenic substances

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-05-01
• Primary Completion: 2018-07-01
• Status Verified: 2018-09
• Study Completion: 2018-09-01
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age >18 years

Exclusion Criteria

• Chronic malabsorption
• Recurrent urinary tract infections
• History of kidney stones

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 2	Water	A=oligomineral water, B=bicarbonate-rich water
Phase 3	Water	A=bicarbonate-rich water, B=oligomineral water
Phase 1	Water	A=oligomineral water, B=oligomineral water
Phase 4	Water	A=bicarbonate-rich water, B=bicarbonate-rich water

Primary Outcome Measures

Name	Time	Method
Urine composition	Assessed the same day of water ingestion

Trial Locations

Locations (1)

Divisione di Nefrologia, Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy