- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509780
The Mineral Water of Vichy and the Urinary Alkalization: A Study of the Dose - Effect of Bicarbonate Salt Water on the Urinary pH in Healthy Volunteers
Vichy water is a type of spring water which traditionally comes from the famous spa town of Vichy, France. The springs which feed Vichy carry a high amount of dissolved minerals. Alkaline salts such as sodium bicarbonate are a primary ingredient in Vichy water, along with calcium and magnesium carbonates.
Bicarbonates alkalinize urine, which is fundamental in preventing and/or diluting uric acid crystals. These are the main component of the uric acid stones or even oxalate stones, which generally " use " a crystal of uric acid as nucleus for stone formation. Cystine stones can also be treated by alkalinizing urine.
Any disorder leading to a low urinary pH ( < 5.5 ) may predispose to stone formation. In this context , the solution of uric acid and the prevention and treatment of uric acid stones can be obtained by alkalization of the urine . The ideal alkalization is achieved when a urinary pH of 6-6.5 can be reached.
The aim of this study is to evaluate the quantity of daily intake of the Vichy water necessary to obtain this alkalization of the urine. There are no data available in the literature about the relationship between the absolute quantity of Vichy water taken and the urinary pH ; nor about the possible influence of the Body Mass Index on this relationship.
Study Overview
Detailed Description
Vichy water is a type of spring water which traditionally comes from the famous spa town of Vichy, France. The springs which feed Vichy carry a high amount of dissolved minerals, and they create a distinctive naturally effervescent bubbling water. Alkaline salts such as sodium bicarbonate are a primary ingredient in Vichy water, along with calcium and magnesium carbonates. The water is sometimes slightly odorous, with substances like sulfur naturally bubbling up with the water. The water also has a distinct taste, due to the dissolved minerals.
Bicarbonates alkalinize urine, which is fundamental in preventing and/or diluting uric acid crystals. These are the main component of the uric acid stones or even oxalate stones , which generally " use " a crystal of uric acid as nucleus for stone formation. Cystine stones can also be treated by alkalinizing urine.
Three conditions influence the potential for uric acid stone formation : the quantitative excretion of uric acid , the volume of urine as it affects the urinary concentration of uric acid, and the urinary pH which seems to be the most important pathogenic factor . Uric acid is a weak acid with a pKa of 5.35 at 37° C . At that pH , half of the uric acid is present as the urate salt and half as free uric acid . Because sodium urate is approximately 20 times more soluble than the free acid, the relative proportion present as free uric acid strongly determinates the risk of stone formation . Low urinary pH increases concentrations of sparingly soluble undissociated uric acid, which leads to direct precipitation of uric acid .
Any disorder leading to a low urinary pH ( < 5.5 ) may predispose to stone formation. For example a chronic metabolic acidosis can lead to a low urinary pH, a hypercalciuria and a hypocitraturia . "Gouty diathesis " refers to a stone - forming propensity characterized by low urinary pH of unknown etiology with or without associated gouty arthritis.
In this context , the solution of uric acid and the prevention and treatment of uric acid stones can be obtained by alkalization of the urine. The ideal alkalization is achieved when a urinary pH of 6-6.5 can be reached.
The aim of this study is to evaluate the quantity of daily intake of the Vichy water necessary to obtain this alkalization of the urine. There are no data available in the literature about the relationship between the absolute quantity of Vichy water taken and the urinary pH ; nor about the possible influence of the Body Mass Index on this relationship.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1020
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers between 18 and 50 years of age
- Available to participate for the planned duration of the study
- Able and willing to complete the study process
Exclusion Criteria:
- Renal disease
- Diabetes
- Hypertension
- Heart failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vichy
|
Volunteers will be asked during 3 days to take their usual intake of fluids.
For the following 7 days, they will take the usual intake of fluids plus 250 ml of Vichy water at 1 pm.
For the following 7 days, they will take the usual intake of fluids plus 250 ml of Vichy water at 7 am and 7 pm.
Ph and density measurement of urine will be made three times a day, at 7 am, 2 pm and 8 pm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily mean urine pH value (normal intake of fluids)
Time Frame: Day 1
|
The study starts with a 3 days "running" period with usual intake of fluids.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 1
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 4
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 4
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 11
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 11
|
Daily mean urine pH value (normal intake of fluids)
Time Frame: Day 2
|
The study starts with a 3 days "running" period with usual intake of fluids.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 2
|
Daily mean urine pH value (normal intake of fluids)
Time Frame: Day 3
|
The study starts with a 3 days "running" period with usual intake of fluids.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 3
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 5
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 5
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 6
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 6
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 7
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 7
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 8
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 8
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 9
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 9
|
Daily mean urine pH value (250 ml Vichy)
Time Frame: Day 10
|
After the three days running period, a 7 days period is observed with usual intake of fluids plus 250 ml of Vichy water at 1 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick ( at 7 am, at 2 pm and at 8 pm), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 10
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 12
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 12
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 13
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 13
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 14
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 14
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 15
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 15
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 16
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 16
|
Daily mean urine pH value (500 ml Vichy)
Time Frame: Day 17
|
Afterwards follows a 7 days period with usual intake of fluids plus 500 ml of Vichy water, divided in two doses: one intake at 7am and one intake at 7 pm.
Each study day three samples of urine are collected for pH measurement with a pH indicator stick (at 7 am, at 2 pm , and at 8 pm ), and density measurement.
Daily mean pH value will be computed.
A urine specific density test (comparing the density of urine to the density of water) is a simple method to verify that total fluid intake doesn't vary substantially between the different study periods.
|
Day 17
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Marie Demeyer, MD, CHU Brugmann
- Principal Investigator: Panagiotis DROLAPAS, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUB-Vichy
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
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Vichy
-
Institute of Skin and Product Evaluation, ItalyActive, not recruitingRosacea | Sensitive SkinItaly
-
Cosmetique Active InternationalCompleted
-
L'OrealCompleted
-
Institut National de la Santé Et de la Recherche...Terminated