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Dietary Counseling + Potassium Supplement for High Blood Pressure

Phase 3

Recruiting

Led By Swapnil Hiremath, MD MPH

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Increased hypersensitivity to potassium (e.g. paramyotonia congenital or adynamia episodica hereditaria)

Adrenal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks to 52 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether dietary changes or potassium supplements are more effective in increasing potassium intake and lowering blood pressure.

Who is the study for?

Adults diagnosed with high blood pressure and low potassium intake are eligible. They must be willing to undergo dietary counseling, potentially take a potassium supplement, and use effective contraception if of childbearing potential. Exclusions include severe liver disease, uncontrolled diabetes, certain heart conditions, psychiatric disorders affecting study participation, allergies to trial ingredients, abnormal blood potassium levels or kidney function.

What is being tested?

The trial is testing whether dietary counseling alone or combined with a potassium supplement can effectively increase potassium intake in patients with high blood pressure. Initially, participants receive diet advice; those not reaching target levels after 4 weeks will also get a potassium supplement.

What are the potential side effects?

Possible side effects may include gastrointestinal issues due to the increased intake of dietary or supplemental potassium. Specific side effects related to individual health conditions have not been detailed but monitoring for any adverse reactions will occur throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure.

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I am 18 or older and, if I can have children, I use effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am highly sensitive to potassium due to a genetic condition.

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I have been diagnosed with adrenal insufficiency.

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I have been diagnosed with primary hyperaldosteronism.

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I have severe heart disease or my heart's pumping ability is very low.

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I have severe liver disease.

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My kidney function is reduced.

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My diabetes is not under control (HbA1C >12%).

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I have a stomach or intestine disorder like ulcers or swallowing problems.

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I have extensive tissue damage from burns.

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I am currently taking potassium supplements for a condition like kidney stones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful increase in potassium intake

Secondary study objectives

Gastrointestinal Events

Hyperkalemia Events

Persistence of increase in potassium intake at 52 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dietary CounsellingExperimental Treatment1 Intervention

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.

Group II: Potassium Citrate SupplementActive Control2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Counselling

2016

Completed Phase 3

~330

0 / 12Eligibility criteria met