Potassium and Sodium to Control Blood Pressure in Hypertensives
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, sodium-restricted
diet, potassium-supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000509
First Posted
October 27, 1999
Last Updated
March 14, 2017
Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000509
Brief Title
Potassium and Sodium to Control Blood Pressure in Hypertensives
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 1983 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, sodium-restricted
Intervention Type
Behavioral
Intervention Name(s)
diet, potassium-supplementation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3241259
Citation
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.
Results Reference
background
PubMed Identifier
2406601
Citation
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.
Results Reference
background
Learn more about this trial
Potassium and Sodium to Control Blood Pressure in Hypertensives
We'll reach out to this number within 24 hrs