Sodium Sensitivity in African Americans

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000536
• Other study ID #: 79
• Secondary ID: R01HL046630
• Status: Completed
• Phase: Phase 2
• First received: October 27, 1999
• Last updated: February 24, 2016
• Start date: July 1992
• Est. completion date: June 1997

Study information

• Verified date: February 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 64 Years
• Eligibility: No eligibility criteria

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Vascular Diseases

Intervention

Behavioral:
• sodium, dietary

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Flack JM, Grimm RH Jr, Staffileno BA, Dnsc, Elmer P, Yunis C, Hedquist L, Dudley A. New salt-sensitivity metrics: variability-adjusted blood pressure change and the urinary sodium-to-creatinine ratio. Ethn Dis. 2002 Winter;12(1):10-9. — View Citation