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NCT Number: NCT07460882

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-sodium salt substitute

Dietary Supplement

The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)

Primary outcomes

  1. Incident hyperkalemia (K ≥5.5 mmol/L)

    Time frame: 4 and 8 weeks

  2. 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

Secondary outcomes

  1. Change in serum potassium levels

    Time frame: 4 and 8 weeks

  2. Change in systolic and diastolic blood pressure (mmHg)

    Time frame: 4 and 8 weeks

  3. Number of Participants Adherent to LSSS use

    Time frame: 4 and 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Junichi Ishigami, MD, PhD

CONTACT

[email protected]

14432877262

Sohel Reza Choudhury, MD, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart Foundation of Bangladesh
  • Vital Strategies

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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