The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension

August 20, 2026 updated by: Johns Hopkins University

The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are:

Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population?

Does initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels?

Participants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

607

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Junichi Ishigami, MD, PhD
  • Phone Number: 14432877262
  • Email: jishiga1@jhu.edu

Study Contact Backup

  • Name: Sohel Reza Choudhury, MD, PhD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥18 years with clinically diagnosed hypertension treated with medication [on a stable dose at least for 2 months]
  • Have a phone for contact

Exclusion Criteria:

  • Those with baseline K ≥5.0 or K <3.0 mmol/L
  • Advanced kidney disease (eGFR <45 ml/min/1.73m2).
  • Those on potassium sparing diuretics (e.g., spironolactone)
  • Other medical conditions determined by physicians (e.g., heart failure treated with medication; life expectancy less than 12 months)
  • Dine out for dinner more than 3 times a week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low sodium salt substitute (LSSS)
Participants are asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt
Dietary supplement: Low-sodium salt substitute
The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incident hyperkalemia (K ≥5.5 mmol/L)
Time Frame: 4 and 8 weeks
4 and 8 weeks
Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)
Time Frame: 4 and 8 weeks
4 and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum potassium levels
Time Frame: 4 and 8 weeks
4 and 8 weeks
Change in systolic and diastolic blood pressure (mmHg)
Time Frame: 4 and 8 weeks
4 and 8 weeks
Number of Participants Adherent to LSSS use
Time Frame: 4 and 8 weeks
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart Foundation of Bangladesh
Vital Strategies

Investigators

  • Principal Investigator: Junichi Ishigami, MD, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00520279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional review board restrictions and participant privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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