NCT Number: NCT00000509
Potassium and Sodium to Control Blood Pressure in Hypertensives
To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.
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Notify MeKey information
Age range
45 year–68 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 3
About this study
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 After 12 weeks of intervention, antihypertensive drugs were withdrawn.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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
diet, potassium-supplementation
BehavioralSponsors and collaborators
Lead sponsor
University of Minnesota
Other
Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
Registry information
Important dates
- Study start
- 1983
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Oct 28, 1999
- Registry last updated
- Mar 16, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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