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

September 16, 2018 updated by: Pietro Manuel Ferraro, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Divisione di Nefrologia, Fondazione Policlinico Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1
A=oligomineral water, B=oligomineral water
Other: Water
1 liter of water in meals; 1 liter out of meals
Experimental: Phase 2
A=oligomineral water, B=bicarbonate-rich water
Other: Water
1 liter of water in meals; 1 liter out of meals
Experimental: Phase 3
A=bicarbonate-rich water, B=oligomineral water
Other: Water
1 liter of water in meals; 1 liter out of meals
Experimental: Phase 4
A=bicarbonate-rich water, B=bicarbonate-rich water
Other: Water
1 liter of water in meals; 1 liter out of meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine composition
Time Frame: Assessed the same day of water ingestion
Assessed the same day of water ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 43111/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe