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IRCT20240121060757N1 IRCT 2024-02-17 Karaj University of Medical Sciences 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. 2025-06-01 anticipated 500 Complete https://irct.ir/trial/75076 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. 3 Hypertension. 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 using sodium salt and can be employed for daily cooking and other routine uses. Intervention 2: Control Group: Patients receive normal salt (100% sodium chloride) and are instructed to continue using this salt as usual for their daily cooking and other daily uses. Yes - There is a plan to make this available What will be shared: Data will be available on reasonable request. When: Data will be available on reasonable request after submitting papers To whom: Data will be available on reasonable request. Conditions: Data will be available on reasonable request. Where to obtain: Data will be available on reasonable request from corresponding author. How to obtain: Data will be available on reasonable request. Comments:
public Dr. Mostafa Qorbani
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 mqorbani1379@yahoo.com Karaj University of Medical Sciences scientific Mostafa Qorbani
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 mqorbani1379@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) 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 40 years 65 years Both Patients using potassium-sparing diuretics, taking potassium supplements, or with any known acute or chronic kidney disease (CKD) are excluded from the study. I10 Essential (primary) hypertension Treatment - Other Treatment - Other 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 using sodium salt and can be employed for daily cooking and other routine uses. Control Group: Patients receive normal salt (100% sodium chloride) and are instructed to continue using this salt as usual for their daily cooking and other daily uses. 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. The mean of 24-hour sodium excretion. 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 and 6 months after the intervention) after consuming salt instead of sodium. Method of measurement: Urine test. The mean of 24-hour potassium excretion. 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: Urine test. 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. Karaj University of Medical Sciences Approved 2024-01-13 Ethics committee of Alborz University of Medical Sciences Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr Karaj Alborz Iran (Islamic Republic of)