NCT03447847

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

February 21, 2018

Last Update Submit

September 16, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Urine composition

    Assessed the same day of water ingestion

Study Arms (4)

Phase 1

EXPERIMENTAL

A=oligomineral water, B=oligomineral water

Other: Water

Phase 2

EXPERIMENTAL

A=oligomineral water, B=bicarbonate-rich water

Other: Water

Phase 3

EXPERIMENTAL

A=bicarbonate-rich water, B=oligomineral water

Other: Water

Phase 4

EXPERIMENTAL

A=bicarbonate-rich water, B=bicarbonate-rich water

Other: Water

Interventions

WaterOTHER

1 liter of water in meals; 1 liter out of meals

Phase 1Phase 2Phase 3Phase 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divisione di Nefrologia, Fondazione Policlinico Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

  • Ferraro PM, Baccaro R, Baroni S, D'Alessandri L, Carpenito C, Di Daniele N, Urbani A, Gambaro G. Effect of water composition and timing of ingestion on urinary lithogenic profile in healthy volunteers: a randomized crossover trial. J Nephrol. 2021 Jun;34(3):875-881. doi: 10.1007/s40620-020-00769-2. Epub 2020 Jun 8.

    PMID: 32514990DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

May 1, 2018

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)