Potassium and Sodium to Control Blood Pressure in Hypertensives

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University of Minnesota (UMN)

Status and phase

Completed
Phase 3

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases
Heart Diseases

Treatments

Behavioral: diet, sodium-restricted
Behavioral: diet, potassium-supplementation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000509
R01HL034767 (U.S. NIH Grant/Contract)
28

Details and patient eligibility

About

To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.

Full description

BACKGROUND: Appropriately increased interest and concern about high blood pressure as a major public health problem coincided with the indication that the risks of hypertension-related morbidity and mortality could be reduced by reduction of blood pressure. Consensus suggestions that individualized approaches be used in treating patients with mild hypertension stimulated further investigations of non-pharmacological methods. Such investigations were also of considerable interest in relation to understanding the physiology of blood pressure control as well as the development of less costly non-drug therapies. Interest was heightened by information suggesting that there might be distinctly harmful side effects related to antihypertensive drug therapy, particularly thiazide diuretics, in some settings. Studies of non-drug therapies included dietary modifications primarily involving weight reduction and sodium restriction with increasing recent concern about other factors such as alcohol intake, dietary fat, calcium, magnesium, and potassium intake. DESIGN NARRATIVE: Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were withdrawn. Follow-up of each participant was for at least two years. The primary endpoint was the proportion of subjects requiring antihypertensive medication at various points following randomization.

Sex

Male

Ages

45 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men, ages 45 to 68. Subjects were hypertensive, were treated for at least 3.5 years with antihypertensive drugs and whose diastolic blood pressure was less than 90 mm Hg.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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