NCT02588352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

October 26, 2015

Last Update Submit

May 18, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Presence of salt sensitivity

    Defined as an increase in mean arterial blood pressure greater than 5 mmHg

    Visit 1 (One Week)

Secondary Outcomes (2)

  • Change in aldosterone level

    Baseline to Visit 2 (One Week)

  • Change in augmentation index (%)

    Baseline to Visit 2 (One Week)

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Open label administration of salt tablets for one week

Dietary Supplement: Salt tablet

Interventions

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

Healthy volunteers

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults age 21-30
  • Able and willing to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Salts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Stuart Katz, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

May 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 19, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)