The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 607
- Primary Endpoint
- Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Low-sodium salt substitute (Dietary Supplement)
Outcomes
Primary Outcomes
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
Incident hyperkalemia (K ≥5.5 mmol/L)
Time Frame: 4 and 8 weeks
Secondary Outcomes
- Change in serum potassium levels(4 and 8 weeks)
- Change in systolic and diastolic blood pressure (mmHg)(4 and 8 weeks)
- Number of Participants Adherent to LSSS use(4 and 8 weeks)