Effects of Potassium Salts on Blood Pressure and Target Organ Damage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by St George's, University of London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00160368
First received: September 8, 2005
Last updated: April 24, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Hypertension
Behavioral: Potassium supplementation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Potassium Bicarbonate and Potassium Chloride on Blood Pressure and Markers of Target Organ Damage in Hypertensives

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.

Secondary Outcome Measures:
  • Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.

Estimated Enrollment: 45
Study Start Date: January 2005
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160368

Contacts
Contact: Feng J He, PhD 0044-20-8725-5375 fhe@sgul.ac.uk
Contact: Graham A MacGregor, MD 0044-20-8725-5774 gmacgregor@sgul.ac.uk

Locations
United Kingdom
St. George's University of London, Recruiting
London, United Kingdom, SW17 0RE
Contact: Feng J He, PhD    0044-20-8725-5375    fhe@sgul.ac.uk   
Contact: Graham A MacGregor, MD    0044-20-8725-5774    gmacgregor@sgul.ac.uk   
Principal Investigator: Feng J He, PhD         
Principal Investigator: Graham A MacGregor, MD         
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Graham A MacGregor, MD St George's, University of London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160368     History of Changes
Other Study ID Numbers: CH/FR/04.0012
Study First Received: September 8, 2005
Last Updated: April 24, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
Hypertension, potassium salts

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014