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Dietary Salt Intake and Vascular Function

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ClinicalTrials.gov Identifier: NCT00590512
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: High sodium Dietary Supplement: Low sodium Early Phase 1

Detailed Description:
Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Dietary Salt Intake and Vascular Function
Study Start Date : March 2005
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Active Comparator: High Sodium
High sodium
Dietary Supplement: High sodium
Active Comparator: Low sodium
Low sodium
Dietary Supplement: Low sodium



Primary Outcome Measures :
  1. endothelial function [ Time Frame: one week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male, African-American volunteers
  2. 18-35 years of age,
  3. No personal or first degree relative with hypertension or diabetes,
  4. Blood pressure <130/85 mmHg and > 90/60 at the screening visit,
  5. Body mass index <30 kg/m2,
  6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).

Exclusion Criteria:

  1. Alcohol intake >2 beverage/night,
  2. Smoking,
  3. Recreational drug use,
  4. Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
  5. Prescription or herbal medication use,
  6. Ischemic changes on resting electrocardiogram,
  7. Known hypersensitivity to any of the study drugs,
  8. Other active medical problems detected by examination or laboratory testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590512


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Rhonda Bentley-Lewis, MD Massachusetts General Hospital
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Responsible Party: Rhonda Bentley-Lewis, MD, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00590512    
Other Study ID Numbers: 2004P002705
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Keywords provided by Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital:
dietary salt
sodium
blood vessels
vascular function
endothelial function
heart disease risk
cardiovascular disease risk