HypertensionNCT01628302
Effect of Salt Restriction on Renin Activation
A study testing Lowering salt in diet in people with Hypertension, run by Turkish Society of Hypertension and Renal Diseases.
Trial summary
The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects. Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Lowering salt in diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2011
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are 50 years and older
- Subjects whose systolic blood pressure is ≥ 140 mmHg
- Subjects whose diastolic blood pressure is ≥ 90 mmHg
- Subjects who is normal weighted defined as body mass index < 25 or who is obese defined as body mass index > 30
- Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
- Informed about the study and consented to include the study
Who cannot join
- Known heart failure
- Known renal failure
- Known chronic liver disease
- Antihypertensive drug use
- nonsteroidal anti inflammatory (NSAI) drug use
About this study
Official title: Investigation of Salt Restriction Effect on Renin Activation
The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects.
Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.
Read the detailed description
The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study.
At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects.
24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days.
- Conditions
- Hypertension
- Being tested
- Lowering salt in diet
- Keywords
- Hypertension,plasma renin activity,salt consumption
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lowering salt in dietBehavioural
Low salt diet (50mmol)for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Normal salt diet | No intervention | The group had normal salt diet (250mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had low salt diet (50mmol) at the last 3 weeks of the study. |
| Low salt diet | Experimental | The group had low salt diet (50mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had normal salt diet at the last 3 weeks of the study. Receives: Behavioral: Lowering salt in diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: 3 weeks
Secondary outcomes (8)
Change in sodium levels in urine samples.
Sodium was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: 3 weeks
Change in plasma renin activity
Plasma renin activity level was measured in the blood samples collected, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: For 3 times in 8 weeks
Change in aldosterone level in blood samples
Aldosterone levels was measured in the blood samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: For 3 times in 8 weeks
Change in potassium levels in urine samples.
Potassium was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: 3 weeks
Change in urea level in urine samples
Urea was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet
Measured: 3 weeks
Change in creatinin level in urine samples
Creatinin was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: 3 weeks
Change in microalbumin level in urine samples
Microalbumin was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet
Measured: 3 weeks
Change in aldosterone level in urine samples
Aldosterone levels was measured in in the 24-hour urine samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Measured: For 3 times in 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Hypertension and Renal Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Arici, Prof., Principal investigator, Hacettepe University Faculty of Medicine Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628302
- Sponsor's protocol ID
- HT-Salt
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Salt Restriction Effect on Renin Activation
- ClinicalTrials.gov ID
- NCT01628302
- Acronym / sponsor ID
- HT-Salt
- Conditions
- Hypertension
- Keywords
- Hypertension,plasma renin activity,salt consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Turkish Society of Hypertension and Renal DiseasesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Jun 2012 (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.
The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects.
Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.
Detailed description
The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study.
At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects.
24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal salt diet | No intervention | –The group had normal salt diet (250mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had low salt diet (50mmol) at the last 3 weeks of the study. |
| Low salt diet | Experimental | Behavioral: Lowering salt in dietThe group had low salt diet (50mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had normal salt diet at the last 3 weeks of the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are 50 years and older
- Subjects whose systolic blood pressure is ≥ 140 mmHg
- Subjects whose diastolic blood pressure is ≥ 90 mmHg
- Subjects who is normal weighted defined as body mass index < 25 or who is obese defined as body mass index > 30
- Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
Key exclusion criteria (5 listed)
- Known heart failure
- Known renal failure
- Known chronic liver disease
- Antihypertensive drug use
- nonsteroidal anti inflammatory (NSAI) drug use
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 |
|---|---|---|
| Lowering salt in dietLow salt diet (50mmol)for three weeks. | Behavioural | Low salt diet |
Primary outcome
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
Time frame: 3 weeks
24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
8 secondary outcomes
Change in sodium levels in urine samples.
Time frame: 3 weeks
Change in plasma renin activity
Time frame: For 3 times in 8 weeks
Change in aldosterone level in blood samples
Time frame: For 3 times in 8 weeks
Change in potassium levels in urine samples.
Time frame: 3 weeks
Change in urea level in urine samples
Time frame: 3 weeks
Change in creatinin level in urine samples
Time frame: 3 weeks
Change in microalbumin level in urine samples
Time frame: 3 weeks
Change in aldosterone level in urine samples
Time frame: For 3 times in 8 weeks
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 Jun 2012.
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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.
Mustafa Arici, Prof. principal investigator
Hacettepe University Faculty of Medicine Department of Nephrology
Questions about this trial
What is this clinical trial studying?
A study testing Lowering salt in diet in people with Hypertension, run by Turkish Society of Hypertension and Renal Diseases.
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 6 inclusion and 5 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks (time frame: 3 weeks). 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 Jun 2012.