HealthyNCT03447847
Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
A study testing Water in people with Healthy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2018to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 years
Who cannot join
- Chronic malabsorption
- Recurrent urinary tract infections
- History of kidney stones
Trial locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
1 liter of water in meals; 1 liter out of meals
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | A=oligomineral water, B=oligomineral water Receives: Other: Water |
| Phase 2 | Experimental | A=oligomineral water, B=bicarbonate-rich water Receives: Other: Water |
| Phase 3 | Experimental | A=bicarbonate-rich water, B=oligomineral water Receives: Other: Water |
| Phase 4 | Experimental | A=bicarbonate-rich water, B=bicarbonate-rich water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine composition
Measured: Assessed the same day of water ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 May 2018
- Primary completion1 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Manuel Ferraro, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447847
- Sponsor's protocol ID
- 43111/16
- Status last verified
- Sep 2018
- First submitted
- 21 Feb 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32514990
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
- ClinicalTrials.gov ID
- NCT03447847
- Acronym / sponsor ID
- 43111/16
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Other: WaterA=oligomineral water, B=oligomineral water |
| Phase 2 | Experimental | Other: WaterA=oligomineral water, B=bicarbonate-rich water |
| Phase 3 | Experimental | Other: WaterA=bicarbonate-rich water, B=oligomineral water |
| Phase 4 | Experimental | Other: WaterA=bicarbonate-rich water, B=bicarbonate-rich water |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age >18 years
Key exclusion criteria (3 listed)
- Chronic malabsorption
- Recurrent urinary tract infections
- History of kidney stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water1 liter of water in meals; 1 liter out of meals | Other | Phase 1, Phase 2, Phase 3, Phase 4 |
Primary outcome
Urine composition
Time frame: Assessed the same day of water ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 32514990Ferraro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water in people with Healthy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine composition (time frame: Assessed the same day of water ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.