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Dietary Salt Intake and Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 28, 2007
First Posted Date  ICMJE January 10, 2008
Last Update Posted Date August 29, 2013
Study Start Date  ICMJE March 2005
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
endothelial function [ Time Frame: one week ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Salt Intake and Vascular Function
Official Title  ICMJE Dietary Salt Intake and Vascular Function
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.
Detailed Description Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: High sodium
  • Dietary Supplement: Low sodium
Study Arms  ICMJE
  • Active Comparator: High Sodium
    High sodium
    Intervention: Dietary Supplement: High sodium
  • Active Comparator: Low sodium
    Low sodium
    Intervention: Dietary Supplement: Low sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2013)
133
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2008)
120
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00590512
Other Study ID Numbers  ICMJE 2004P002705
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rhonda Bentley-Lewis, MD Massachusetts General Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP