Protocol summary
-
Study aim
-
the effect of potassium-enriched salt substitute compared to sodium salt on blood pressure control in hypertensive patients
-
Design
-
A double-blind, randomized, controlled, parallel-group, phase three clinical trial of 500 patients.
-
Settings and conduct
-
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
-
Participants/Inclusion and exclusion criteria
-
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 groups
-
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)
-
Main outcome variables
-
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.
General information
-
Reason for update
-
New changes have been made due to the comments of the reviewers of the journal to which we submitted the protocol article.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20240121060757N1
Registration date:
2024-02-17, 1402/11/28
Registration timing:
prospective
Last update:
2025-04-08, 1404/01/19
Update count:
2
-
Registration date
-
2024-02-17, 1402/11/28
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2025-06-01, 1404/03/11
-
Expected recruitment end date
-
2026-04-30, 1405/02/10
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
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.
-
Public title
-
Effect of potassium-enriched salt versus sodium salt on control of blood pressure
-
Purpose
-
Treatment
-
Inclusion/Exclusion 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:
Patients using potassium-sparing diuretics, taking potassium supplements, or with any known acute or chronic kidney disease (CKD) are excluded from the study.
-
Age
-
From 40 years old to 65 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
500
-
Randomization (investigator's opinion)
-
Randomized
-
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 (investigator's opinion)
-
Double blinded
-
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.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-01-13, 1402/10/23
-
Ethics committee reference number
-
IR.ABZUMS.REC.1402.293
Health conditions studied
1
-
Description of health condition studied
-
Hypertension
-
ICD-10 code
-
I10
-
ICD-10 code description
-
Essential (primary) hypertension
Primary outcomes
1
-
Description
-
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
2
-
Description
-
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
3
-
Description
-
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 outcomes
1
-
Description
-
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
2
-
Description
-
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
3
-
Description
-
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
4
-
Description
-
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
5
-
Description
-
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
6
-
Description
-
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
7
-
Description
-
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
8
-
Description
-
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
Intervention groups
1
-
Description
-
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.
-
Category
-
Treatment - Other
2
-
Description
-
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.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Karaj University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
Data will be available on reasonable request.
-
When the data will become available and for how long
-
Data will be available on reasonable request after submitting papers
-
To whom data/document is available
-
Data will be available on reasonable request.
-
Under which criteria data/document could be used
-
Data will be available on reasonable request.
-
From where data/document is obtainable
-
Data will be available on reasonable request from corresponding author.
-
What processes are involved for a request to access data/document
-
Data will be available on reasonable request.
-
Comments
-