Healthy VolunteersNCT02588352
Evaluation of Salt Sensitivity in Young Adults
A study testing Salt tablet in people with Healthy Volunteers, run by NYU Langone Health at 1 site in United States.
Trial summary
The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Salt tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2015
- 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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults age 21-30
- Able and willing to provide written informed consent
Who cannot join
- Any cardiovascular or other chronic health problem
- Chronic medications besides oral contraceptive pills in women
- BMI>30kg/m2
- Blood pressure >140/90 mmHg
- Inability or unwillingness to adhere to study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.
Read the detailed description
Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.
This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.
The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.
- Conditions
- Healthy Volunteers
- Being tested
- Salt tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt tabletDietary supplement
Subjects will be given salt tablets and instructed to take 4 grams of sale three times a day (total of 12 grams of salt/day) for one week
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Open label administration of salt tablets for one week Receives: Dietary Supplement: Salt tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of salt sensitivity
Defined as an increase in mean arterial blood pressure greater than 5 mmHg
Measured: Visit 1 (One Week)
Secondary outcomes (2)
Change in aldosterone level
change in serum aldosterone level
Measured: Baseline to Visit 2 (One Week)
Change in augmentation index (%)
Change in augmentation index determined by radial artery tonometry
Measured: Baseline to Visit 2 (One Week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Katz, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588352
- Sponsor's protocol ID
- 12-01669
- Status last verified
- May 2016
- First submitted
- 26 Oct 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be kept on a local server and will be available for sharing based on evaluation of requests from investigators. The transfer of data outside of NYU will be conducted via signed DTA signed by both institutions.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salt Sensitivity in Young Adults
- ClinicalTrials.gov ID
- NCT02588352
- Acronym / sponsor ID
- 12-01669
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Oct 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.
The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.
Detailed description
Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.
This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.
The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Dietary Supplement: Salt tabletOpen label administration of salt tablets for one week |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young adults age 21-30
- Able and willing to provide written informed consent
Key exclusion criteria (5 listed)
- Any cardiovascular or other chronic health problem
- Chronic medications besides oral contraceptive pills in women
- BMI>30kg/m2
- Blood pressure >140/90 mmHg
- Inability or unwillingness to adhere to study procedures
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 |
|---|---|---|
| Salt tabletSubjects will be given salt tablets and instructed to take 4 grams of sale three times a day (total of 12 grams of salt/day) for one week | Dietary supplement | Healthy volunteers |
Primary outcome
Presence of salt sensitivity
Time frame: Visit 1 (One Week)
Defined as an increase in mean arterial blood pressure greater than 5 mmHg
2 secondary outcomes
Change in aldosterone level
Time frame: Baseline to Visit 2 (One Week)
Change in augmentation index (%)
Time frame: Baseline to Visit 2 (One Week)
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 19 May 2016.
- Individual participant dataSharing planned: Yes. De-identified data will be kept on a local server and will be available for sharing based on evaluation of requests from investigators. The transfer of data outside of NYU will be conducted via signed DTA signed by both institutions.
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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.
Stuart Katz, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt tablet in people with Healthy Volunteers, run by NYU Langone Health at 1 site in United States.
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 2 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 19 May 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 United States. 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?
Presence of salt sensitivity (time frame: Visit 1 (One Week)). 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 19 May 2016.