HealthySODIVASCNCT02561325
Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects
A study testing Sodium Bicarbonate and Sodium chloride in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sodium Bicarbonate and Sodium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Mar 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not treated and/or family history of arterial high blood pressure (Father or Mother),
- Between 18 and 75 years old
- Asymptomatic on the cardiovascular plan,
- Absence of known heart disorder,
- Brachial Perimeter between 22 and 42 cms,
- Creatinine clearance in the standards dating less than 12 months, (glomerular filtration rate > 60 ml / mn / 1.73m²),
Show all 12Show fewer
- Agreeing to drink some sparkling water during the periods of study,
- Effective method of birth control for women with childbearing potential
- Cooperation and understanding enough to conform to the study obligations
- Voluntary gives written informed consent to participate in the study
- Affiliated at system of French social security
- Inscription or acceptation of inscription in the national register of volunteers involved in trials.
Who cannot join
- -Treated by corticoids
- Treated by prohibited medications
- Pregnant or breastfeeding
- Treated by anti-hypertensive drug
- History of heart disease or ischemic heart disease
- Lack of sinus rhythm
Show all 18Show fewer
- Renal insufficiency (glomerular filtration rate > 60 ml / mn / 1.73m ²)
- Uncontrolled hypertension (> 160 / 100mmHg)
- Incompatible comorbidity with the study
- BMI > 35 kg / m2
- Invalidating cognitive disorders
- Anxiety to use the device to measure blood pressure alone at home judged by the investigator
- Diabetes (Type I and II)
- Chronic alcoholism
- Sports judged as intense (more than 3 hours per week of intense sports),
- Participation in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial,
- Cooperation and understanding that do not allow him to follow the trial,
- Patients with minor or under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Gisèle PICKERING
About this study
Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.
In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."
Read more
"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.
In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.
Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
Read the detailed description
Pre-selection: Clinical Pharmacology Center or Cardiology department
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
- Signature of informed consent form
- Check of eligibility criteria
- Clinical exam
- Blood pressure measure
- Blood sample (for renal biology)
- Collection of concomitant treatments
- Collection of food habits
- Delivery of the dietary instructions and forbidden treatments
Phenotyping period : (192 subjects)
All the 192 subjects will realize the 3 first visits in order to determine if yes or no the subjects are "Sodium sensitive".
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
- Signature of informed consent form
- Check of eligibility criteria
- Clinical exam
- Blood pressure measure
- Blood sample (for renal biology)
- Collection of concomitant treatments
- Collection of food habits
- Delivery of the dietary instructions and forbidden treatments
Visit 2: General practitioner's office or Clinical Pharmacology Center
- Collection of adverse events and concomitant treatment
- Check of biological analysis
- Clinical examination
- Blood pressure measure
- Attribution of treatment for 2 weeks
- Delivery of a diary and of the blood pressure measure device
Visit 3 : General practitioner's office or Clinical Pharmacology Center
- Return of the diary, the blood pressure measure device and the treatment
- Collection of adverse events and concomitant treatment
- Extraction of the data of blood pressure
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 4
Determination of the subjects " sodium sensitive ". Sodium sensitive subjects will continue the study and non-sodium sensitive subjects will stop the study.
Wash-out period n°1 (2 weeks at least) pursuit of the dietary instructions.
Cross over study - Clinical Pharmacology Center :Center (48 subjects)
All the subjects will realize the 4 visits of the cross over study, and will received Nacl and placebo according to the randomisation plan.
Visit 4 and visit 6 contained the same interventions for the participant (exept the consultation with the dietetician) and visit 5 et 7 are the same regarding the interventions for the participant.
First period
Visit 4 - Day 0 :
- Return of the urinary bottle
- Collection of adverse events and concomitant treatment
- Clinical examination
- Blood pressure measure
- Arterial compliance (non invasive)
- Pregancy test (for women of childbearing age)
- Measure of weight and height
- Impedancemetry
- Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay)
- Assay of urinary sodium excretion
- Consultation with a dietician.
- Delivery of a diet record , and a booklet to be completed every day of the study period
- Reminder of the use of the blood pressure measure device
- Delivery of the study treatment according to the randomisation plan :
6.51 g of NaCl per day to distribute on the various meals + 1.5 liters of spring water (poor in sodium) to drink each day, Or placebo NaCl every day to distribute on the various meals + 1.5 liters of spring water (with sodium bicarbonate) to drink each day.
Every day during 14 days The first take of treatment will be done on the Clinical Pharmacology Center
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 5
Visit 5 (Day 14) :
- Return of the urinary bottle, of the empty treatment (to check compliance), of the diet record and of the booklet
- Collection of adverse events and concomitant treatment
- Clinical examination
- Blood pressure measure
- Arterial compliance (non invasive)
- Measure of weight
- Impedancemetry
- Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay)
- Assay of urinary sodium excretion
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 6
Wash-out 2 (at least 2 weeks) pursuit of the dietary instructions.
Second study period
Visit 6 (day28) - beginning period 2
Visite 7 (Day42) - end of period 2 and end of study
This second period is the same as the first period, except that the subject will not have the consultation with the dietetician and will receive the other study treatment according to the randomization plan.
Ancillary Study This trial contains an ancillary study of genotypage (optional with specific consent of the subject) with the aim of the confrontation with the phenotyping.
For that purpose, a blood sample will be made in the period of selection on the subject who gives their consent, in the same time of the blood sample for renal biology at visit 1.
These results would allow to identify biomarkers of blood pressure sensibility at the sodium.
- Conditions
- Healthy
- Being tested
- Sodium Bicarbonate and Sodium chloride
- Keywords
- Blood pressure, Sodium Chloride, Sodium Bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate and Sodium chlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| NaCI group | Experimental | a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. Receives: Drug: Sodium Bicarbonate and Sodium chloride |
| placebo NaCI | Placebo comparator | a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. Receives: Drug: Sodium Bicarbonate and Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average value of the mean blood pressures
Average value of the mean blood pressures, collected with the device Microlife BP A200, in the morning and evening during the last 3 days of each of the 2 periods of treatment of 14 days.
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Secondary outcomes (9)
Value of Aortic Systolic Pressure (SP) with device Sphygmocor ®,
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of Pulse Pressure (PP), with device Sphygmocor ®,
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of the Increase Index (AIX) with the Sphygmocor ®,
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of the Pusle Wave Velocity with the Sphygmocor ®,
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days.
Biological assay of Renine (pg/ml)
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Values of fat mass, dry mass and water by impedancemetry.
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological assay Aldostéron (pg/ml)
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological assay Angiotensine II (UECA)
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological Assay of the Endotheliales microparticles (nb/µl)
Measured: during the last 3 days of each of the 2 periods of treatment of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
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.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude DUBRAY, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561325
- Sponsor's protocol ID
- CHU-0244
- Acronym
- SODIVASC
- Status last verified
- Jul 2016
- First submitted
- 8 Sep 2015
- Last updated
- 26 Jul 2016
- Results posted
- 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
- Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects
- ClinicalTrials.gov ID
- NCT02561325
- Acronym / sponsor ID
- SODIVASC / CHU-0244
- Conditions
- Healthy
- Keywords
- Blood pressure, Sodium Chloride, Sodium Bicarbonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Sep 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.
Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.
In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."
"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.
In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.
Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
Detailed description
Pre-selection: Clinical Pharmacology Center or Cardiology department
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
- Signature of informed consent form
- Check of eligibility criteria
- Clinical exam
- Blood pressure measure
- Blood sample (for renal biology)
- Collection of concomitant treatments
- Collection of food habits
- Delivery of the dietary instructions and forbidden treatments
Phenotyping period : (192 subjects)
All the 192 subjects will realize the 3 first visits in order to determine if yes or no the subjects are "Sodium sensitive".
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
- Signature of informed consent form
- Check of eligibility criteria
- Clinical exam
- Blood pressure measure
- Blood sample (for renal biology)
- Collection of concomitant treatments
- Collection of food habits
- Delivery of the dietary instructions and forbidden treatments
Visit 2: General practitioner's office or Clinical Pharmacology Center
- Collection of adverse events and concomitant treatment
- Check of biological analysis
- Clinical examination
- Blood pressure measure
- Attribution of treatment for 2 weeks
- Delivery of a diary and of the blood pressure measure device
Visit 3 : General practitioner's office or Clinical Pharmacology Center
- Return of the diary, the blood pressure measure device and the treatment
- Collection of adverse events and concomitant treatment
- Extraction of the data of blood pressure
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 4
Determination of the subjects " sodium sensitive ". Sodium sensitive subjects will continue the study and non-sodium sensitive subjects will stop the study.
Wash-out period n°1 (2 weeks at least) pursuit of the dietary instructions.
Cross over study - Clinical Pharmacology Center :Center (48 subjects)
All the subjects will realize the 4 visits of the cross over study, and will received Nacl and placebo according to the randomisation plan.
Visit 4 and visit 6 contained the same interventions for the participant (exept the consultation with the dietetician) and visit 5 et 7 are the same regarding the interventions for the participant.
First period
Visit 4 - Day 0 :
- Return of the urinary bottle
- Collection of adverse events and concomitant treatment
- Clinical examination
- Blood pressure measure
- Arterial compliance (non invasive)
- Pregancy test (for women of childbearing age)
- Measure of weight and height
- Impedancemetry
- Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay)
- Assay of urinary sodium excretion
- Consultation with a dietician.
- Delivery of a diet record , and a booklet to be completed every day of the study period
- Reminder of the use of the blood pressure measure device
- Delivery of the study treatment according to the randomisation plan :
6.51 g of NaCl per day to distribute on the various meals + 1.5 liters of spring water (poor in sodium) to drink each day, Or placebo NaCl every day to distribute on the various meals + 1.5 liters of spring water (with sodium bicarbonate) to drink each day.
Every day during 14 days The first take of treatment will be done on the Clinical Pharmacology Center
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 5
Visit 5 (Day 14) :
- Return of the urinary bottle, of the empty treatment (to check compliance), of the diet record and of the booklet
- Collection of adverse events and concomitant treatment
- Clinical examination
- Blood pressure measure
- Arterial compliance (non invasive)
- Measure of weight
- Impedancemetry
- Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay)
- Assay of urinary sodium excretion
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 6
Wash-out 2 (at least 2 weeks) pursuit of the dietary instructions.
Second study period
Visit 6 (day28) - beginning period 2
Visite 7 (Day42) - end of period 2 and end of study
This second period is the same as the first period, except that the subject will not have the consultation with the dietetician and will receive the other study treatment according to the randomization plan.
Ancillary Study This trial contains an ancillary study of genotypage (optional with specific consent of the subject) with the aim of the confrontation with the phenotyping.
For that purpose, a blood sample will be made in the period of selection on the subject who gives their consent, in the same time of the blood sample for renal biology at visit 1.
These results would allow to identify biomarkers of blood pressure sensibility at the sodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaCI group | Experimental | Drug: Sodium Bicarbonate and Sodium chloridea clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. |
| placebo NaCI | Placebo comparator | Drug: Sodium Bicarbonate and Sodium chloridea clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- - Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not treated and/or family history of arterial high blood pressure (Father or Mother),
- Between 18 and 75 years old
- Asymptomatic on the cardiovascular plan,
- Absence of known heart disorder,
- Brachial Perimeter between 22 and 42 cms,
Key exclusion criteria (18 listed)
- -Treated by corticoids
- Treated by prohibited medications
- Pregnant or breastfeeding
- Treated by anti-hypertensive drug
- History of heart disease or ischemic heart disease
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 |
|---|---|---|
| Sodium Bicarbonate and Sodium chloride | Drug | NaCI group, placebo NaCI |
Primary outcome
Average value of the mean blood pressures
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Average value of the mean blood pressures, collected with the device Microlife BP A200, in the morning and evening during the last 3 days of each of the 2 periods of treatment of 14 days.
9 secondary outcomes
Value of Aortic Systolic Pressure (SP) with device Sphygmocor ®,
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of Pulse Pressure (PP), with device Sphygmocor ®,
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of the Increase Index (AIX) with the Sphygmocor ®,
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days.
Value of the Pusle Wave Velocity with the Sphygmocor ®,
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days.
Biological assay of Renine (pg/ml)
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Values of fat mass, dry mass and water by impedancemetry.
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological assay Aldostéron (pg/ml)
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological assay Angiotensine II (UECA)
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Biological Assay of the Endotheliales microparticles (nb/µl)
Time frame: during the last 3 days of each of the 2 periods of treatment of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Claude DUBRAY principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate and Sodium chloride in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 12 inclusion and 18 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: status not confirmed, 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 France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average value of the mean blood pressures (time frame: during the last 3 days of each of the 2 periods of treatment of 14 days). 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.