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Effects of Potassium Salts on Blood Pressure and Target Organ Damage

NCT ID: NCT00160368

Last Updated: 2007-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Potassium supplementation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St George's, University of London

OTHER

Sponsor Role lead

Principal Investigators

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Graham A MacGregor, MD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

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St. George's University of London,

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Feng J He, PhD

Role: CONTACT

[email protected]
0044-20-8725-5375

Graham A MacGregor, MD

Role: CONTACT

[email protected]
0044-20-8725-5774

Facility Contacts

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Feng J He, PhD

Role: primary

[email protected]
0044-20-8725-5375

Graham A MacGregor, MD

Role: backup

[email protected]
0044-20-8725-5774

Other Identifiers

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CH/FR/04.0012

Identifier Type: -

Identifier Source: org_study_id