ClinicalTrials.Veeva

Menu

Increasing Potassium Intake in Hypertensive Individuals

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Conditions

Hypertension

Treatments

Other: High potassium diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02759367
MSH 08-0025-A

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

High potassium diet group
Experimental group
Description:
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.
Treatment:
Other: High potassium diet
Usual diet group
No Intervention group
Description:
Individuals in this group were asked to continue habitual dietary intake.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems