Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial

20180873-01H

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.

2019-12-01

2025-02-01

2025-11-01

Recruiting

Early phase I

120

Inclusion Criteria: 1. Provides signed and dated informed consent form 2. 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) 3. 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) 4. 24-Hour Urine K \< 60 mmol/day Exclusion Criteria: 1. Serum Potassium \< 3.3 or \> 5.1 mmol/L 2. Glomerular Filtration Rate \< 45 ml/min/1.73m2 3. Primary hyperaldosteronism 4. Pregnancy or lactation 5. Psychiatric disorder which, in the opinion of the investigator, would interfere with the study, or inability to give consent 6. Severe Liver disease 7. Metabolic Alkalosis (HCO3 \> 32 mmol/L) 8. Exclude patients who need to be started on renin-angiotensin-aldosterone blockade in the first 3 months 9. Gastrointestinal disorder (e.g. delayed gastric emptying, dysphagia, oesophageal/gastric/duodenal ulcer) 10. Presence of cardiac disease (sever myocardial damage, heart failure, or clinical changes in congestive heart failure, ejection fraction \<35%) 11. Uncontrolled diabetes mellitus (HbA1C \>12%) 12. Acute dehydration 13. Extensive tissue damage (burns) 14. Increased hypersensitivity to potassium (e.g. paramyotonia congenital or adynamia episodica hereditaria) 15. Patients taking other potassium supplements for another indication (eg. kidney stones) 16. Acidosis (pH\<7.11) 17. Adrenal insufficiency 18. Allergies to any of the investigational product ingredients (medicinal and non- medicinal) 19. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-04-14