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.
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General information
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Revision for manuscript according journal comments
Revision for manuscript according journal comments
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به دلیل نظرات داوران ژورنالی که مقاله پروتوکول را سابمیت کردیم
به دلیل نظرات داوران ژورنالی که مقاله پروتوکول را سابمیت کردیم
Patients aged 40 to 65 with a diagnosis of first or second stage hypertension by a doctor.
Patients with blood pressure who are undergoing treatment with blood pressure medication
Patients who primarily consume home-cooked meals
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
Patients aged 40 to 65 with a diagnosis of first or second stage hypertension by a doctorconfirmed 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
بیماران 40 تا 65 ساله مبتلا به فشار خون مرحله اول یا دوم که توسط پزشک تشخیص داده شده باشند.
بیماران مبتلا به فشار خون که تحت درمان با داروی فشار خون باشند.
بیمارانی که عمدتاً غذاهای خانگی مصرف می کنند.
بیماران 40 تا 65 ساله مبتلا به فشار خون مرحله اول یا دوم که توسط پزشک تشخیص داده شده باشند. فشار خون بیش از 135 میلیمتر جیوه
بیماران مبتلا به فشار خون که تحت درمان با داروی فشار خون باشند.
بیمارانی که عمدتاً غذاهای خانگی مصرف می کنند.
بیمار و خانواده اش رضایتنامه آگاهانه را تکمیل کنند
بیماران 40 تا 65 ساله مبتلا به فشار خون مرحله اول یا دوم که توسط پزشک تشخیص داده شده باشند. فشار خون بیش از 135 میلیمتر جیوه بیماران مبتلا به فشار خون که تحت درمان با داروی فشار خون باشند. بیمارانی که عمدتاً غذاهای خانگی مصرف می کنند. بیمار و خانواده اش رضایتنامه آگاهانه را تکمیل کنند
Secondary outcomes
#1
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
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
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
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
#2
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
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
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
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
#3
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
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
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
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
#4
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.
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.
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.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
#5
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
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
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
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
#6
empty
Number/percent of individuals who develope hyperkalemia and hypokalemia
Number/percent of individuals who develope hyperkalemia and hypokalemia
empty
تعداد یا درصد افراد دچار هیپر یا هیپوکالمی
تعداد یا درصد افراد دچار هیپر یا هیپوکالمی
empty
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
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
empty
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
empty
Biochemical test
Biochemical test
empty
آزمایش
آزمایش
#7
empty
Occurrence of CVD events such as TIA, cardiovascular accidents, occurrence/reoccurrence of strokes and reoccurrence of hypertensive crisis
Occurrence of CVD events such as TIA, cardiovascular accidents, occurrence/reoccurrence of strokes and reoccurrence of hypertensive crisis
empty
عوارض مرتبط با قلب و عروق همچون تعداد سکته ها و غیره
عوارض مرتبط با قلب و عروق همچون تعداد سکته ها و غیره
empty
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
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
empty
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
empty
Questionnaire
Questionnaire
empty
ثبت در پرسشنامه
ثبت در پرسشنامه
#8
empty
Acceptability, usage, tolerance and taste of the blended salt and attitudes
Acceptability, usage, tolerance and taste of the blended salt and attitudes
empty
پذیرش مزه نمک و جایگزین آن
پذیرش مزه نمک و جایگزین آن
empty
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
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
empty
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
اندازه گیری در ابتدا مطالعه (پیش از شروع مداخله) و انتهای مطالعه (3 و 6 ماه پس از مداخله) پس از مصرف نمک جایگزین سدیم انجام می شود.
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
Sharing plan
undecided
yes
undecidedyes
no
yes
noyes
no
yes
noyes
no
yes
noyes
no
yes
noyes
no
yes
noyes
There is no further information
empty
There is no further information
اطلاعات بیشتری وجود ندارد
empty
اطلاعات بیشتری وجود ندارد
empty
Data will be available on reasonable request.
Data will be available on reasonable request.
empty
در صورت درخواست معقول دتا در دسترس خواهد بود
در صورت درخواست معقول دتا در دسترس خواهد بود
empty
Data will be available on reasonable request after submitting papers
Data will be available on reasonable request after submitting papers
empty
در صورت درخواست معقول دتا در دسترس خواهد بود
در صورت درخواست معقول دتا در دسترس خواهد بود
empty
Data will be available on reasonable request.
Data will be available on reasonable request.
empty
در صورت درخواست معقول دتا در دسترس خواهد بود
در صورت درخواست معقول دتا در دسترس خواهد بود
empty
Data will be available on reasonable request.
Data will be available on reasonable request.
empty
در صورت درخواست معقول دتا در دسترس خواهد بود
در صورت درخواست معقول دتا در دسترس خواهد بود
empty
Data will be available on reasonable request from corresponding author.
Data will be available on reasonable request from corresponding author.
empty
در صورت درخواست معقول از نویسنده مسئول دتا در دسترس خواهد بود
در صورت درخواست معقول از نویسنده مسئول دتا در دسترس خواهد بود
empty
Data will be available on reasonable request.
Data will be available on reasonable request.
empty
در صورت درخواست معقول دتا در دسترس خواهد بود
در صورت درخواست معقول دتا در دسترس خواهد بود
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
Revision for manuscript according journal comments
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060757N1
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2025-03-16, 1403/12/26
Update count:2
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Mostafa Qorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 3705
Email address
m.qorbani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-19, 1403/12/29
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Alireza Dehghan Nayeri
Street address
Shahid Rajaee Hospital, Behesti Ave, Iran
City
Karaj
Province
Alborz
Postal code
3194635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
nami.m.kh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Razieh Lotfi
Street address
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
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
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mostafa Qorbani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
mqorbani1379@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mostafa Qorbani
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
mqorbani1379@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ehsan Shahrestanaki
Position
Non-academic researcher
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Deputy of Research and Technology, Alborz University of Medical Sciences Alborz, Safarian Street, 45-Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
shahrestanakie3472@gmail.com
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