HealthyNCT02509780
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
A study testing Vichy in people with Healthy, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
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. 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?
- Vichy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Jul 2016
- 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
- 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
Who cannot join
- Renal disease
- Diabetes
- Hypertension
- Heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Vichy
- Keywords
- Vichy, urine alkalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VichyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vichy | Experimental | Not described Receives: Other: Vichy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily mean urine pH value (normal intake of fluids)
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.
Measured: Day 1
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 4
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 11
Daily mean urine pH value (normal intake of fluids)
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.
Measured: Day 2
Daily mean urine pH value (normal intake of fluids)
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.
Measured: Day 3
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 5
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 6
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 7
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 8
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 9
Daily mean urine pH value (250 ml Vichy)
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.
Measured: Day 10
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 12
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 13
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 14
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 15
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 16
Daily mean urine pH value (500 ml Vichy)
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.
Measured: Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Marie De Meyer, Brugmann University Hospital
- Investigators
- Jean-Marie Demeyer, MD, Principal investigator, CHU BrugmannPanagiotis DROLAPAS, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509780
- Sponsor's protocol ID
- CHUB-Vichy
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02509780
- Acronym / sponsor ID
- CHUB-Vichy
- Conditions
- Healthy
- Keywords
- Vichy, urine alkalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Jul 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vichy | Experimental | Other: Vichy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Renal disease
- Diabetes
- Hypertension
- Heart failure
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 |
|---|---|---|
| VichyVolunteers 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. | Other | Vichy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 26 Jul 2016.
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Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Jean-Marie Demeyer, MD principal investigator
CHU Brugmann
Panagiotis DROLAPAS, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vichy in people with Healthy, run by Brugmann University Hospital at 1 site in Belgium.
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 3 inclusion and 4 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 26 Jul 2016. 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 Belgium. 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?
Daily mean urine pH value (normal intake of fluids) (time frame: Day 1). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.