Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02759367
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Potassium Intake in Hypertensive Individuals
Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Organization:
Study Overview
Official Title:
Adequate Intake of Potassium Does Not Cause Hyperkalemia in Hypertensive Individuals on Medications That Antagonize the Renin Angiotensin Aldosterone System
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.
Detailed Description:
The blood pressure lowering benefits of increasing dietary potassium (K⁺) are well known. As such dietary recommendations for hypertension focus on a diet rich in high K⁺ food sources such as fruits and vegetables. An important theme to be addressed is the safety of achieving high dietary K⁺ intake in hypertensive individuals who are also receiving medical therapy that might predispose to elevated serum K⁺ levels (hyperkalemia).
The purpose of this study was to assess the impact of aggressively increasing dietary K⁺ on serum K⁺ concentrations in hypertensive individuals with intact renal function medicated with RAAS blocking drugs. The investigators hypothesized that dietary K⁺ supplementation would not provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (ACEi) or an angiotensin receptor blocker (ARB).
The investigators conducted an open controlled clinical trial in 20 hypertensive subjects with normal renal function who were randomized to a usual diet group (UD n=10), or a high potassium diet group (HKD, n= 10). Fruits and vegetables were used to increase potassium intake. All participants were on an ACEi or and ARB. Serum potassium concentration, 3- day food records and 24 Hour urine collections were completed at baseline and at the end of the 4-week study.
The purpose of this study was to assess the impact of aggressively increasing dietary K⁺ on serum K⁺ concentrations in hypertensive individuals with intact renal function medicated with RAAS blocking drugs. The investigators hypothesized that dietary K⁺ supplementation would not provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (ACEi) or an angiotensin receptor blocker (ARB).
The investigators conducted an open controlled clinical trial in 20 hypertensive subjects with normal renal function who were randomized to a usual diet group (UD n=10), or a high potassium diet group (HKD, n= 10). Fruits and vegetables were used to increase potassium intake. All participants were on an ACEi or and ARB. Serum potassium concentration, 3- day food records and 24 Hour urine collections were completed at baseline and at the end of the 4-week study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: