Dietary Counseling or Potassium Supplement to Increase Potassium Intake in Patients With High Blood Pressure

NCT03809884 | Completed Phase 3 DMC

• 1 other identifier: 20180873-01H
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

High blood pressure; Potassium; Potassium Citrate; Dietary Counselling; Hypertension

Outcome Measures

Primary Outcomes (1)

• Successful increase in potassium intake

  As estimated by 24 hour urine results at 4 weeks, achieving a urinary sodium \> 90 mmol/day.

  4 weeks

Secondary Outcomes (3)

• Persistence of increase in potassium intake at 52 weeks

  52 weeks

• Hyperkalemia Events

  4 weeks to 52 weeks

• Gastrointestinal Events

  4 weeks to 52 weeks

Study Arms (2)

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.

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).

Behavioral: Dietary Counselling; Drug: Potassium Citrate

Interventions

Dietary Counselling BEHAVIORAL

Individually tailored strategy to increase potassium in the diet.

Dietary Counselling; Potassium Citrate Supplement

Potassium Citrate DRUG

Dosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution).

Also known as: K-Citra

Potassium Citrate Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Hour Urine K \< 60 mmol/day

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 1A2, Canada

Location

Related Publications (1)

• 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.

  PMID: 35164833 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Swapnil Hiremath, MD MPH

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: January 18, 2019
• Study Start: December 1, 2019
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)