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Effects of Potassium Salts on Blood Pressure and Target Organ Damage

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Potassium supplementation
Sponsored by
St George's, University of London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, potassium salts

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. George's University of London,Recruiting

Outcomes

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.

Full Information

First Posted
September 8, 2005
Last Updated
April 24, 2007
Sponsor
St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00160368
Brief Title
Effects of Potassium Salts on Blood Pressure and Target Organ Damage
Official Title
Effect of Potassium Bicarbonate and Potassium Chloride on Blood Pressure and Markers of Target Organ Damage in Hypertensives
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, potassium salts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Potassium supplementation
Primary Outcome Measure Information:
Title
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.
Secondary Outcome Measure Information:
Title
Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng J He, PhD
Phone
0044-20-8725-5375
Email
fhe@sgul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Graham A MacGregor, MD
Phone
0044-20-8725-5774
Email
gmacgregor@sgul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham A MacGregor, MD
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. George's University of London,
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng J He, PhD
Phone
0044-20-8725-5375
Email
fhe@sgul.ac.uk
First Name & Middle Initial & Last Name & Degree
Graham A MacGregor, MD
Phone
0044-20-8725-5774
Email
gmacgregor@sgul.ac.uk
First Name & Middle Initial & Last Name & Degree
Feng J He, PhD
First Name & Middle Initial & Last Name & Degree
Graham A MacGregor, MD

12. IPD Sharing Statement

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Effects of Potassium Salts on Blood Pressure and Target Organ Damage

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