High blood pressure is the leading cause of cardiovascular disease worldwide. Many medicines are available to lower blood pressures successfully, as well as many non-medical options, such as dietary changes. Some effective dietary changes include decreasing sodium and increasing potassium in the diet. A lot of focus has been on sodium intake yet; potassium intake in the diet remains low amongst adult Canadians. Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke.
The overall purpose of this study is to reveal the most effective way of increasing potassium, amongst participants with high blood pressure whose existing intake of potassium is low. In the first stage, participants with high blood pressure and proven low potassium intake will receive dietary counselling. If after 4 weeks, there has not been a desired increase in potassium intake, the patients will be prescribed an additional potassium supplement.
Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: Dietary Counselling Drug: Potassium Citrate | Phase 3 |
High blood pressure is the leading cause of cardiovascular disease worldwide, including in Canada. The prevalence of high blood pressure is steadily rising, with growing and ageing population. Many medicines are available to decrease blood pressures successfully, as well as many non-medical options, such as dietary changes and exercise. There is a marked preference amongst patients, reiterated in a recent Hypertension Canada report, for more research into methods for controlling blood pressure without medicines or to reduce the burden of taking many pills to control high blood pressure. Indeed, effective options do exist, especially with diet, specifically decreasing sodium and increasing potassium in diet. Both these recommendations are also made by organizations worldwide including the World Health Organization as well as Hypertension Canada. Though a lot of focus has been on sodium intake in the public health outreach, even the potassium intake in diet remains woefully low amongst adult Canadians. Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke. The advice most often provided is to 'eat more fruits and vegetables' which does not get translated into concrete change.
The Investigators propose to do a clinical trial in two stages (as an adaptive trial design). In the first stage, participants with high blood pressure and proven low potassium intake (measured on the basis of collecting urine for 24 hours) will get individually tailored dietary advice, reinforced by weekly supportive phone/email support. If at 4 weeks, there has not been a desired increase in potassium intake, the patients will be prescribed an additional potassium supplement. Testing at 4 weeks will be conducted again to confirm the efficacy of the potassium supplement. Final measurements will be planned at 52 weeks to observe and measure the persistence of the effect of diet or additional supplement. Concurrent measurements of sodium intake, blood pressure, participant satisfaction, safety measures will also be done.
The results of the study would help determine the most effective method of increasing potassium intake, thus reducing blood pressure, need for blood pressure lowering medicines, at the same time potentially increasing participant satisfaction. The current guidelines recommend changes in diet (not supplement) to increase potassium intake, hence the two stage design will only add supplements if the most rigorous dietary advice does not work. The Investigators have received letters of support from the World Hypertension League and Hypertension Canada in support of the research design and for dissemination and implementation of the findings.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial |
Actual Study Start Date : | December 1, 2019 |
Estimated Primary Completion Date : | February 2022 |
Estimated Study Completion Date : | February 2024 |
Arm | Intervention/treatment |
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Experimental: Dietary Counselling
All enrolled patients will undergo a 1:1 counselling with a registered dietitian (with possible inclusion of family members, as appropriate). The dietitian will undertake an assessment of the comorbidities (e.g. diabetes), dietary intake, dietary habits (e.g. eating out, food preparation, socio-cultural aspects) and provide an individually tailored strategy to increase potassium in the diet. Secondly, on a weekly basis, the dietitian will contact the patient by telephone, or electronically (as preferred by the patient) to reinforce the advice and provide support/advice as necessary.
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Behavioral: Dietary Counselling
Individually tailored strategy to increase potassium in the diet.
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Active Comparator: Potassium Citrate Supplement
Patients who are not able to successfully increase their potassium intake at 4 weeks with dietary counselling will receive potassium citrate supplements. They will receive oral potassium supplementation in the form of 50 to 100 mmol of potassium citrate (as 25 to 50 ml of the liquid solution).
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Behavioral: Dietary Counselling
Individually tailored strategy to increase potassium in the diet.
Drug: Potassium Citrate Dosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution).
Other Name: K-Citra
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica Wagner, BSc | 613-738-8400 ext 81625 | jewagner@toh.ca | |
Contact: Julie Leidecker | 613-738-8400 ext 81623 | jleidecker@toh.ca |
Canada, Ontario | |
Jessica Wagner | Recruiting |
Ottawa, Ontario, Canada, K1H 1A2 | |
Contact: Jessica Wagner 613-738-8400 ext 81625 jewagner@toh.ca | |
Principal Investigator: Swapnil Hiremath, MD PhD | |
Sub-Investigator: Marcel Ruzicka, MD MPH |
Principal Investigator: | Swapnil Hiremath, MD MPH | The Ottawa Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | December 13, 2018 | ||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||
Last Update Posted Date | March 3, 2021 | ||||||||
Actual Study Start Date ICMJE | December 1, 2019 | ||||||||
Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Successful increase in potassium intake [ Time Frame: 4 weeks ] As estimated by 24 hour urine results at 4 weeks, achieving a urinary sodium > 90 mmol/day.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Dietary Counseling or Potassium Supplement to Increase Potassium Intake in Patients With High Blood Pressure | ||||||||
Official Title ICMJE | Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial | ||||||||
Brief Summary |
High blood pressure is the leading cause of cardiovascular disease worldwide. Many medicines are available to lower blood pressures successfully, as well as many non-medical options, such as dietary changes. Some effective dietary changes include decreasing sodium and increasing potassium in the diet. A lot of focus has been on sodium intake yet; potassium intake in the diet remains low amongst adult Canadians. Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke. The overall purpose of this study is to reveal the most effective way of increasing potassium, amongst participants with high blood pressure whose existing intake of potassium is low. In the first stage, participants with high blood pressure and proven low potassium intake will receive dietary counselling. If after 4 weeks, there has not been a desired increase in potassium intake, the patients will be prescribed an additional potassium supplement. |
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Detailed Description |
High blood pressure is the leading cause of cardiovascular disease worldwide, including in Canada. The prevalence of high blood pressure is steadily rising, with growing and ageing population. Many medicines are available to decrease blood pressures successfully, as well as many non-medical options, such as dietary changes and exercise. There is a marked preference amongst patients, reiterated in a recent Hypertension Canada report, for more research into methods for controlling blood pressure without medicines or to reduce the burden of taking many pills to control high blood pressure. Indeed, effective options do exist, especially with diet, specifically decreasing sodium and increasing potassium in diet. Both these recommendations are also made by organizations worldwide including the World Health Organization as well as Hypertension Canada. Though a lot of focus has been on sodium intake in the public health outreach, even the potassium intake in diet remains woefully low amongst adult Canadians. Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke. The advice most often provided is to 'eat more fruits and vegetables' which does not get translated into concrete change. The Investigators propose to do a clinical trial in two stages (as an adaptive trial design). In the first stage, participants with high blood pressure and proven low potassium intake (measured on the basis of collecting urine for 24 hours) will get individually tailored dietary advice, reinforced by weekly supportive phone/email support. If at 4 weeks, there has not been a desired increase in potassium intake, the patients will be prescribed an additional potassium supplement. Testing at 4 weeks will be conducted again to confirm the efficacy of the potassium supplement. Final measurements will be planned at 52 weeks to observe and measure the persistence of the effect of diet or additional supplement. Concurrent measurements of sodium intake, blood pressure, participant satisfaction, safety measures will also be done. The results of the study would help determine the most effective method of increasing potassium intake, thus reducing blood pressure, need for blood pressure lowering medicines, at the same time potentially increasing participant satisfaction. The current guidelines recommend changes in diet (not supplement) to increase potassium intake, hence the two stage design will only add supplements if the most rigorous dietary advice does not work. The Investigators have received letters of support from the World Hypertension League and Hypertension Canada in support of the research design and for dissemination and implementation of the findings. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
120 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 2024 | ||||||||
Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03809884 | ||||||||
Other Study ID Numbers ICMJE | 20180873-01H | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ottawa Hospital Research Institute | ||||||||
Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Ottawa Hospital Research Institute | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |