Effects of Potassium Salts on Blood Pressure and Target Organ Damage

April 24, 2007 updated by: St George's, University of London

Effect of Potassium Bicarbonate and Potassium Chloride on Blood Pressure and Markers of Target Organ Damage in Hypertensives

The purpose of this study is to determine the effect of potassium chloride and potassium bicarbonate on blood pressure and also to determine whether increasing potassium intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease, as well as on bone health.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomised trials have shown that increasing potassium intake lowers blood pressure. However, most previous trials used potassium chloride. Whereas, potassium in fruits and vegetables is not a chloride salt, but a mixture of potassium phosphate, sulphate, citrate, and many organic anions, most of which are precursors of potassium bicarbonate. It is unclear whether non-chloride salt of potassium has greater or lesser effect on blood pressure compared to potassium chloride.

Experimental studies in animals and epidemiological studies in humans suggest that a high potassium intake may have beneficial effects on the cardiovascular system and the kidney, independent of its effect on blood pressure, and also reduce the risk of osteoporosis.

We propose to carry out a randomised double-blind trial to compare potassium bicarbonate with potassium chloride looking at their effect on blood pressure, and also to determine whether these potassium salts have beneficial effects on the cardiovascular system, kidney and bone health.

Comparisons: potassium chloride vs potassium bicarbonate vs placebo.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • Recruiting
        • St. George's University of London,
        • Contact:
          • Feng J He, PhD
          • Phone Number: 0044-20-8725-5375
          • Email: fhe@sgul.ac.uk
        • Contact:
        • Principal Investigator:
          • Feng J He, PhD
        • Principal Investigator:
          • Graham A MacGregor, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with untreated essential hypertension (sitting systolic blood pressure between 140 and 170 mmHg and/or sitting diastolic blood pressure between 90 and 105 mmHg);
  • Age 18 - 75 years.

Exclusion Criteria:

  • Individuals younger than 18 or older than 75 years;
  • Individuals with impaired renal function with plasma creatinine greater than 120 umol/L for non-blacks or 150 umol/L for blacks;
  • Individuals with chronic diarrhea, or history of peptic ulcer;
  • Individuals with baseline plasma potassium values greater than 5.0 mmol/L;
  • Individuals with severe hypertension i.e. blood pressure > 170/105 mmHg;
  • Individuals with diabetes mellitus;
  • Individuals with any secondary cause of hypertension;
  • Individuals with malignancy or liver disease;
  • Individuals with ischaemic heart disease or heart failure;
  • Females who are pregnant or breast feeding or on the oral contraceptive pill.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.

Secondary Outcome Measures

Outcome Measure
Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Graham A MacGregor, MD, St George's, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

April 25, 2007

Last Update Submitted That Met QC Criteria

April 24, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH/FR/04.0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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