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Effect of potassium-enriched salt versus sodium salt on control of blood pressure

Comparing the efficacy of potassium-enriched salt substitutes versus sodium salt on blood pressure control in patients with hypertension: a double-blind randomized clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240121060757N1
Enrollment
500
Registered
2024-02-17
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension. Essential (primary) hypertension

Interventions

Intervention 1: Intervention Group: Patients are provided with a sodium salt substitute containing 70% sodium and 30% potassium chloride. They are instructed that using potassium salt is equivalent to

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 40 to 65 with confirmed HTN (having measured SBP>= 135mmHg). Patients with blood pressure who are undergoing treatment with blood pressure / anti-hypertensive medication Patients who primarily consume home-cooked meals Participants with written informed consent from both themselves and all their households

Exclusion criteria

Exclusion criteria: Patients using potassium-sparing diuretics, taking potassium supplements, or with any known acute or chronic kidney disease (CKD) are excluded from the study.

Design outcomes

Primary

MeasureTime frame
The mean of systolic blood pressure. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Mercury sphygmomanometer.;The mean of diastolic blood pressure. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Mercury sphygmomanometer.;The mean of blood pressure. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Mercury sphygmomanometer.

Secondary

MeasureTime frame
Urinary sodium to potassium ratio. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3 & 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: The result of dividing the sodium and potassium ratio of urine.;Serum creatinine. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3 & 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Blood test.;Attitude of using regular salt or salt substitute. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3 & 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Questionnaire.;Number/percent of individuals who develope hyperkalemia and hypokalemia. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3 & 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Biochemical test.;Occurrence of CVD events such as TIA, cardiovascular accidents, occurrence/reoccurrence of strokes and reoccurrence of hypertensive crisis. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3& 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Questionnaire.;Acceptability, usage, tolerance and taste of the blended salt and attitudes. Timepoint: The measurement is done at the beginning of the study (before the start of the intervention) and at the end of the study (3&6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Questionnaire.;The mean of 24-hour sodium excretion. Timepoint: The measurement is done

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mostafa Qorbani

Karaj University of Medical Sciences

mqorbani1379@yahoo.com+98 26 3464 3705

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026