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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks to 52 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful increase in potassium intake
Secondary outcome measures
Gastrointestinal Events
Hyperkalemia Events
Persistence of increase in potassium intake at 52 weeks

Side effects data

From 2011 Phase 4 trial • 83 Patients • NCT00357331
19%
Gastrointestinal Symptoms
5%
Hyperkalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Potassium Citrate
Placebo

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

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,571 Total Patients Enrolled
Swapnil Hiremath, MD MPHPrincipal InvestigatorThe Ottawa Hospital
1 Previous Clinical Trials

Media Library

Dietary Counselling Clinical Trial Eligibility Overview. Trial Name: NCT03809884 — Phase 3
High Blood Pressure Research Study Groups: Potassium Citrate Supplement, Dietary Counselling
High Blood Pressure Clinical Trial 2023: Dietary Counselling Highlights & Side Effects. Trial Name: NCT03809884 — Phase 3
Dietary Counselling 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809884 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples of research where Dietary Counselling has been used?

"There are currently 8 clinical trials underway that are researching the efficacy of dietary counselling. 1 of those trials is in Phase 3. Although many of the studies for dietary counselling are based in Shanghai, there are a total of 14 locations across the globe that are conducting these trials."

Answered by AI

What do most people use Dietary Counselling for?

"Many patients with kidney stones find relief through Dietary Counselling. This same treatment can also ameliorate symptoms for those struggling with renal tubular acidosis, laxative, and dyschezia."

Answered by AI

What are the risks associated with Dietary Counselling?

"There is existing clinical data that suggests dietary counselling is effective and safe, so it received a score of 3."

Answered by AI

How many people are being given the chance to participate in this clinical trial?

"Indeed, the clinicaltrials.gov website reveals that this study is still looking for patients. First posted on December 1st, 2019 and last updated October 31st, 2022, the trial requires 120 participants from 2 different sites."

Answered by AI

Are people still able to join this clinical trial?

"From what is detailed on clinicaltrials.gov, this research is actively recruiting patients. The listing was first put up on December 1st 2019 and has been edited as recently as October 31st 2022."

Answered by AI

Who else is applying?

What site did they apply to?
Ottawa Hospital Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Never been in any clinical trial. Never been seriously ill before & I was recently diagnosed with Progressive Pulmonary Fibrosis in 2022. I’m a father of seven (7) children under 13 years of age & I have everything to live for & I want to bit this terrible illness so badly & I’m willing to try any experimental drug.
PatientReceived no prior treatments
~19 spots leftby Feb 2025