Effects of Potassium Salts on Blood Pressure and Target Organ Damage
Information source: St George's, University of London
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Potassium supplementation (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: St George's, University of London Official(s) and/or principal investigator(s):
Graham A MacGregor, MD, Principal Investigator, Affiliation: St George's, University of London
Overall contact:
Feng J He, PhD, Phone: 0044-20-8725-5375, Email: fhe@sgul.ac.uk
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.
Clinical Details
Official title: Effect of Potassium Bicarbonate and Potassium Chloride on Blood Pressure and Markers of Target Organ Damage in Hypertensives
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.
Secondary outcome: Comparisons among different treatments in blood pressure and markers of target organ damage and 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Feng J He, PhD, Phone: 0044-20-8725-5375, Email: fhe@sgul.ac.uk
St. George's University of London,, London SW17 0RE, United Kingdom; Recruiting
Feng J He, PhD, Phone: 0044-20-8725-5375, Email: fhe@sgul.ac.uk
Graham A MacGregor, MD, Phone: 0044-20-8725-5774, Email: gmacgregor@sgul.ac.uk
Feng J He, PhD, Principal Investigator
Graham A MacGregor, MD, Principal Investigator
Additional Information
Starting date: January 2005
Ending date: March 2008
Last updated: April 24, 2007
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