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Sodium Sensitivity in African Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000536
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
  Purpose
To compare the effects of two levels of dietary sodium on blood pressure in Black men and women, and to determine what factors predict the degree of response.

Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Behavioral: sodium, dietary Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Study Start Date: July 1992
Estimated Study Completion Date: June 1997
Detailed Description:

BACKGROUND:

The study permitted a more precise estimate of the effects of sodium chloride on blood pressure in Blacks and a systematic examination of sodium sensitivity defined by various methods. The results had significance in answering questions about risk factors for blood pressure in Blacks and for defining sodium sensitivity.

DESIGN NARRATIVE:

Double-blind, two-period cross-over. All participants were given six weeks of intensive nutritional counseling to lower 24-hour urine sodium output from an estimated 165 mEq/24 hours at baseline to less than 140 mEq/24 hours. Only those participants who excreted less than 140 mEq /24 hours after six weeks of intensive dietary sodium intervention and had greater than 70 percent adherence to study capsules were eligible for randomization. Eligible subjects were assigned to one of two treatment sequences: 100 mEq of sodium chloride capsules per day during period one followed by placebo capsules during period two; placebo capsules during period one followed by 100 mEq of sodium chloride capsules per day during period two. The major endpoint was change in diastolic and systolic blood pressure. A number of other measures were carried out, including blood chemistries, glucose tolerance (glucose and insulin), insulin resistance, urinary kallikrein, serum renin, and plasma norepinephrine. Other major aims of the trial included testing general new diagnostic criteria for sodium sensitivity, examining predictors of sodium sensitivity, and examining how changes in sodium intake influenced change in specific metabolic parameters. The trial design incorporated careful control of the dietary changes and strict standardization of blood pressure measurement with a random-zero device. The study was extended through June 1997 on FY 1995 funds.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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): NCT00000536


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Richard Grimm, Jr. University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000536     History of Changes
Other Study ID Numbers: 79
R01HL046630 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Vascular Diseases