Evaluation of Salt Sensitivity in Young Adults
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salt tablet
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Young adults age 21-30
- Able and willing to provide written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy volunteers
Arm Description
Open label administration of salt tablets for one week
Outcomes
Primary Outcome Measures
Presence of salt sensitivity
Defined as an increase in mean arterial blood pressure greater than 5 mmHg
Secondary Outcome Measures
Change in aldosterone level
change in serum aldosterone level
Change in augmentation index (%)
Change in augmentation index determined by radial artery tonometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02588352
Brief Title
Evaluation of Salt Sensitivity in Young Adults
Official Title
Evaluation of Salt Sensitivity in Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Open label administration of salt tablets for one week
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt tablet
Intervention Description
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
Primary Outcome Measure Information:
Title
Presence of salt sensitivity
Description
Defined as an increase in mean arterial blood pressure greater than 5 mmHg
Time Frame
Visit 1 (One Week)
Secondary Outcome Measure Information:
Title
Change in aldosterone level
Description
change in serum aldosterone level
Time Frame
Baseline to Visit 2 (One Week)
Title
Change in augmentation index (%)
Description
Change in augmentation index determined by radial artery tonometry
Time Frame
Baseline to Visit 2 (One Week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Young adults age 21-30
Able and willing to provide written informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Evaluation of Salt Sensitivity in Young Adults
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