Evaluation of Salt Sensitivity in Young Adults

Healthy Volunteers Clinical Trial

Official title:

Evaluation of Salt Sensitivity in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588352
• Other study ID #: 12-01669
• Status: Completed
• Phase: N/A
• First received: October 26, 2015
• Last updated: May 18, 2016
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 increases in salt intake.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 30 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Salt tablet
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

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of salt sensitivity	Defined as an increase in mean arterial blood pressure greater than 5 mmHg	Visit 1 (One Week)	No
Secondary	Change in aldosterone level	change in serum aldosterone level	Baseline to Visit 2 (One Week)	No
Secondary	Change in augmentation index (%)	Change in augmentation index determined by radial artery tonometry	Baseline to Visit 2 (One Week)	No