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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Have a phone for contact

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Low-sodium salt substitute

    Dietary supplement

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

Treatment groups

607 Participants
are divided into 1 treatment group
Group A: Low sodium salt substitute (LSSS)Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Heart Foundation of Bangladesh

Collaborator

Vital Strategies

Collaborator