Clinical trial NCT00000536: Sodium Sensitivity in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Richard Grimm, Jr.
References:
citation: 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.
citation: Saviano A, Petruzziello C, Riccioni ME, Di Pumpo M, Petrucci M, Brigida M, Zanza C, Candelli M, Franceschi F, Ojetti V. Lower Gastrointestinal Bleeding in the Emergency Department: High- Volume vs. Low-Volume Peg Bowel Preparation for Colonoscopy: A Randomized Trial. Rev Recent Clin Trials. 2023;18(1):76-81. doi: 10.2174/1574887117666220908152754.