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.

the effect of potassium-enriched salt substitute compared to sodium salt on blood pressure control in hypertensive patients

A double-blind, randomized, controlled, parallel-group, phase three clinical trial of 500 patients.

In this double-blind randomized clinical trial, patients with first and second-stage hypertension. Participants are selected through the available sampling method from the health promotion and prevention center of Rajai Hospital in Alborz. The individuals undergo a six-month follow-up period and are randomized into two groups using the block randomization method. One group receives salt replacement, while the other is given normal salt. blinding is implemented for both patients and outcome assessors

Inclusion Criteria: Participants with first or second-stage hypertension diagnosed by a physician or under treatment with antihypertensive medication are included in the study. Only those individuals who primarily consume homemade meals are eligible to participate in the study. Exclusion Criteria: patients or their family members using potassium-sparing diuretics, potassium supplements, or those with known acute or chronic kidney disease (CKD) will be excluded from participation in this study.

Intervention group: The salt substitute intervention comprises a blend of 70% sodium and 30% potassium chloride. Control group: Participants in the control group received regular salt (100% sodium chloride)

The primary outcome of the study focuses on systolic and diastolic blood pressure. Secondary outcomes encompass 24-hour urinary sodium and potassium excretion, urinary sodium-to-potassium ratio, creatinine levels and attitudes toward the use of salt or salt substitutes.

The Permutation Block Randomization method is employed to allocate patients into two groups: intervention and control. The website www.sealedenvelope.com is utilized to generate the randomization blocks, with block sizes set at 4 and 6. The individual (patient) serves as the unit of randomization. Concealment of the randomization sequence is carried out by a person other than the members of the research, following the randomization list created by www.sealedenvelope.com. Sealed opaque letter envelopes are employed for concealment.

Blinding will be implemented for both the patient and the outcome assessor. Participants in the intervention and control groups will receive similar salt packs. Once a patient meets the study criteria, a third person, who is not a member of the research team and is responsible for random allocation and concealment, will assign the individual to either the intervention or control group. This allocation will be determined based on the contents of a sealed envelope, and the corresponding package will be provided. As a result, the person evaluating the results will be kept unaware of the participant's group assignment.