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Not yet recruiting NCT07460882

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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-sodium salt substitute.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Incident hyperkalemia (K ≥5.5 mmol/L) [Time frame: 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]
Secondary outcome measures (3)
  • Change in serum potassium levels [Time frame: 4 and 8 weeks]
  • Change in systolic and diastolic blood pressure (mmHg) [Time frame: 4 and 8 weeks]
  • Number of Participants Adherent to LSSS use [Time frame: 4 and 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07460882 · IRB00520279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗