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Completed

NCT Number: NCT02588352

Evaluation of Salt Sensitivity in Young Adults

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.

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Key information

Conditions

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salt tablet

Dietary 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

Primary outcomes

  1. Presence of salt sensitivity

    Time frame: Visit 1 (One Week)

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

Secondary outcomes

  1. Change in aldosterone level

    Time frame: Baseline to Visit 2 (One Week)

    change in serum aldosterone level

  2. Change in augmentation index (%)

    Time frame: Baseline to Visit 2 (One Week)

    Change in augmentation index determined by radial artery tonometry

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2015
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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