Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000509
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
1999-10-27
Brief Title:
Potassium and Sodium to Control Blood Pressure in Hypertensives
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mEqday 142 subjects into a potassium supplementation 96 mEqday group whose sodium intake was also restricted to no more than 80 mEqday After 12 weeks of intervention antihypertensive drugs were withdrawn Follow-up of each participant was for at least two years The primary endpoint was the proportion of subjects requiring antihypertensive medication at various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
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 mEqday 142 subjects into a potassium supplementation 96 mEqday group whose sodium intake was also restricted to no more than 80 mEqday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL034767 | NIH | None | httpsreporternihgovquickSearchR01HL034767 |