Potassium and Sodium to Control Blood Pressure in Hypertensives

NCT ID: NCT00000509

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1983-09-30
• Study Completion Date: 2003-09-30

Brief Summary

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

Detailed 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 After 12 weeks of intervention, antihypertensive drugs were withdrawn.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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

diet, sodium-restricted

Intervention Type: BEHAVIORAL

diet, potassium-supplementation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Grimm RH, Kofron PM, Neaton JD, Svendsen KH, Elmer PJ, Holland L, Witte L, Clearman D, Prineas RJ. Effect of potassium supplementation combined with dietary sodium reduction on blood pressure in men taking antihypertensive medication. J Hypertens Suppl. 1988 Dec;6(4):S591-3. doi: 10.1097/00004872-198812040-00185.

Reference Type: BACKGROUND

PMID: 3241259 (View on PubMed)

Grimm RH Jr, Neaton JD, Elmer PJ, Svendsen KH, Levin J, Segal M, Holland L, Witte LJ, Clearman DR, Kofron P, et al. The influence of oral potassium chloride on blood pressure in hypertensive men on a low-sodium diet. N Engl J Med. 1990 Mar 1;322(9):569-74. doi: 10.1056/NEJM199003013220901.

Reference Type: BACKGROUND

PMID: 2406601 (View on PubMed)

Other Identifiers

R01HL034767

Identifier Type: NIH

Identifier Source: secondary_id

View Link

28

Identifier Type: -

Identifier Source: org_study_id