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Effects of Potassium Salts on Blood Pressure and Target Organ Damage
This study is currently recruiting participants.
Study NCT00160368   Information provided by St George's, University of London
First Received: September 8, 2005   Last Updated: April 24, 2007   History of Changes

September 8, 2005
April 24, 2007
January 2005
 
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.
Same as current
Complete list of historical versions of study NCT00160368 on ClinicalTrials.gov Archive Site
Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.
Same as current
 
Effects of Potassium Salts on Blood Pressure and Target Organ Damage
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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Hypertension
Behavioral: Potassium supplementation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
45
March 2008
 

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.
Both
18 Years to 75 Years
No
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
United Kingdom
 
NCT00160368
 
CH/FR/04.0012
St George's, University of London
 
Principal Investigator: Graham A MacGregor, MD St George's, University of London
St George's, University of London
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP