Increasing Potassium Intake in Hypertensive Individuals

Adequate Intake of Potassium Does Not Cause Hyperkalemia in Hypertensive Individuals on Medications That Antagonize the Renin Angiotensin Aldosterone System

This study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: High potassium diet

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically treated hypertension as diagnosed Hypertension was established by the participant's cardiologist or if recruited from the online community hypertension was self-reported and confirmed by study investigators based on participant's medical prescription.
• Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous 3 months
• K+ intake at baseline of less than 80 mmol/day (food diary of 24 hour food recall).

Exclusion Criteria:

• Patients with an episode of acute coronary syndrome, or revascularization within the previous 3 months will not be included.
• Serum K+ concentration 5.0 mmol/L
• Serum creatinine > 130 mmol/L.
• Inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High potassium diet group; Individuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables.	Other: High potassium diet; An increase in consumption of high potassium fruits and vegetables
No Intervention: Usual diet group; Individuals in this group were asked to continue habitual dietary intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum potassium concentration	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urinary potassium excretion		4 weeks
3 day dietary food diary	Food record will assess marco and mirco nutrient intake.	4 weeks

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

General Publications

• Malta D, Arcand J, Ravindran A, Floras V, Allard JP, Newton GE. Adequate intake of potassium does not cause hyperkalemia in hypertensive individuals taking medications that antagonize the renin angiotensin aldosterone system. Am J Clin Nutr. 2016 Oct;104(4):990-994. doi: 10.3945/ajcn.115.129635. Epub 2016 Aug 31.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Nutrition; Potassium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: MSH 08-0025-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO