HypertensionPhase 3NCT00160368
Effects of Potassium Salts on Blood Pressure and Target Organ Damage
A Phase 3 study testing Potassium supplementation in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Potassium supplementation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. George's University of London,
London, SW17 0RE
Feng J He, PhD, 0044-20-8725-5375, fhe@sgul.ac.uk
Graham A MacGregor, MD, 0044-20-8725-5774, gmacgregor@sgul.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Potassium supplementation
- Keywords
- Hypertension, potassium salts
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium supplementationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.
Secondary outcomes (1)
Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2005
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Graham A MacGregor, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160368
- Sponsor's protocol ID
- CH/FR/04.0012
- Status last verified
- Apr 2007
- First submitted
- 8 Sep 2005
- Last updated
- 25 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Potassium Bicarbonate and Potassium Chloride on Blood Pressure and Markers of Target Organ Damage in Hypertensives
- ClinicalTrials.gov ID
- NCT00160368
- Acronym / sponsor ID
- CH/FR/04.0012
- Conditions
- Hypertension
- Keywords
- Hypertension, potassium salts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Mar 2008 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium supplementation | Behavioural | – |
Primary outcome
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.
1 secondary outcome
Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham A MacGregor, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Potassium supplementation in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng J He, PhD (0044-20-8725-5375, fhe@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2007.