HypertensionPhase 3NCT03809884
Dietary Counseling or Potassium Supplement to Increase Potassium Intake in Patients With High Blood Pressure
A Phase 3 study testing Dietary Counselling and Potassium Citrate in people with Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Dietary Counselling and Potassium Citrate
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 22 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides signed and dated informed consent form
- Diagnosis of hypertension (either on treatment; or not on treatment with an ambulatory blood pressure monitor (ABPM)- daytime systolic blood pressure (SBP) > 140 or diastolic blood pressure (DBP) > 90)
- Male or female, aged 18 and greater (women of child bearing potential must use highly effective contraception (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants; intrauterine device (IUD) or intrauterine system (IUS); vasectomy of male partner and tubal ligation)
- 24-Hour Urine K < 60 mmol/day
Who cannot join
- Serum Potassium < 3.3 or > 5.1 mmol/L
- Glomerular Filtration Rate < 45 ml/min/1.73m2
- Primary hyperaldosteronism
- Pregnancy or lactation
- Psychiatric disorder which, in the opinion of the investigator, would interfere with the study, or inability to give consent
- Severe Liver disease
Show all 19Show fewer
- Metabolic Alkalosis (HCO3 > 32 mmol/L)
- Exclude patients who need to be started on renin-angiotensin-aldosterone blockade in the first 3 months
- Gastrointestinal disorder (e.g. delayed gastric emptying, dysphagia, oesophageal/gastric/duodenal ulcer)
- Presence of cardiac disease (sever myocardial damage, heart failure, or clinical changes in congestive heart failure, ejection fraction <35%)
- Uncontrolled diabetes mellitus (HbA1C >12%)
- Acute dehydration
- Extensive tissue damage (burns)
- Increased hypersensitivity to potassium (e.g. paramyotonia congenital or adynamia episodica hereditaria)
- Patients taking other potassium supplements for another indication (eg. kidney stones)
- Acidosis (pH<7.11)
- Adrenal insufficiency
- Allergies to any of the investigational product ingredients (medicinal and non- medicinal)
- Patients on any of the following medications should be on a stable dose: angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, beta-blockers, mineralocorticoid receptor antagonists, amiloride, non steroidal antiinflammatory drugs (NSAIDs), beta-blockers, digoxin, and heparin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Dietary Counselling, Potassium Citrate
- Keywords
- High blood pressure, Potassium, Potassium Citrate, Dietary Counselling, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary CounsellingBehavioural
Individually tailored strategy to increase potassium in the diet.
Potassium CitrateDrug
Also called K-Citra
Dosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution).
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counselling | Experimental | 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. Receives: Behavioral: Dietary Counselling |
| Potassium Citrate Supplement | Active comparator | 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). Receives: Behavioral: Dietary Counselling; Drug: Potassium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful increase in potassium intake
As estimated by 24 hour urine results at 4 weeks, achieving a urinary sodium > 90 mmol/day.
Measured: 4 weeks
Secondary outcomes (3)
Persistence of increase in potassium intake at 52 weeks
As estimated by comparison of persistence of change in potassium intake (as estimated by 24 hour urine results) from 4 weeks to 52 weeks.
Measured: 52 weeks
Hyperkalemia Events
Any episodes of hyperkalemia (as defined as a serum potassium greater than the 5.1 mmol/L)
Measured: 4 weeks to 52 weeks
Gastrointestinal Events
Gastrointestinal side effects, specifically changes in bowel habits, belching and/or flatulence; abdominal pain or cramps.
Measured: 4 weeks to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Dec 2019
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swapnil Hiremath, MD MPH, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809884
- Sponsor's protocol ID
- 20180873-01H
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2018
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hiremath S, Fergusson D, Knoll G, Ramsay T, Kong J, Ruzicka M. Diet or additional supplement to increase potassium intake: protocol for an adaptive clinical trial. Trials. 2022 Feb 14;23(1):147. doi: 10.1186/s13063-022-06071-9.
PubMed 35164833
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial
- ClinicalTrials.gov ID
- NCT03809884
- Acronym / sponsor ID
- 20180873-01H
- Conditions
- Hypertension
- Keywords
- High blood pressure, Potassium, Potassium Citrate, Dietary Counselling, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Counselling | Experimental | Behavioral: Dietary CounsellingAll 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. |
| Potassium Citrate Supplement | Active comparator | Behavioral: Dietary Counselling, Drug: Potassium CitratePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provides signed and dated informed consent form
- Diagnosis of hypertension (either on treatment; or not on treatment with an ambulatory blood pressure monitor (ABPM)- daytime systolic blood pressure (SBP) > 140 or diastolic blood pressure (DBP) > 90)
- Male or female, aged 18 and greater (women of child bearing potential must use highly effective contraception (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants; intrauterine device (IUD) or intrauterine system (IUS); vasectomy of male partner and tubal ligation)
- 24-Hour Urine K < 60 mmol/day
Key exclusion criteria (19 listed)
- Serum Potassium < 3.3 or > 5.1 mmol/L
- Glomerular Filtration Rate < 45 ml/min/1.73m2
- Primary hyperaldosteronism
- Pregnancy or lactation
- Psychiatric disorder which, in the opinion of the investigator, would interfere with the study, or inability to give consent
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 |
|---|---|---|
| Dietary CounsellingIndividually tailored strategy to increase potassium in the diet. | Behavioural | Dietary Counselling, Potassium Citrate Supplement |
| Potassium CitrateAlso: K-CitraDosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution). | Drug | Potassium Citrate Supplement |
Primary outcome
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.
3 secondary outcomes
Persistence of increase in potassium intake at 52 weeks
Time frame: 52 weeks
Hyperkalemia Events
Time frame: 4 weeks to 52 weeks
Gastrointestinal Events
Time frame: 4 weeks to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 35164833Hiremath S, Fergusson D, Knoll G, Ramsay T, Kong J, Ruzicka M. Diet or additional supplement to increase potassium intake: protocol for an adaptive clinical trial. Trials. 2022 Feb 14;23(1):147. doi: 10.1186/s13063-022-06071-9.
- Individual participant dataSharing planned: No
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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.
Swapnil Hiremath, MD MPH principal investigator
The Ottawa Hospital
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 Dietary Counselling and Potassium Citrate in people with Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 inclusion and 19 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: finished, as of the sponsor's last update on 9 Apr 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful increase in potassium intake (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809884, which also lists 1 linked publication.
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 9 Apr 2025.