The effects of a reduced-sodium, high-potassium salt substitute on hypertensive and normal population of Baharlou Clinic clients, Tehran, Iran at 2016-2017
The purpose of this intervention is to investigate the consequences of a "low sodium, high potassium" salt on a group of Iranian hypertensive patients and general population. Intervention Group would be 50 hypertensive patients with their family enrolled to receive the low sodium salt (80 percent sodium chloride and 20 percent potassium chloride) for 3 months and Control Group would be 50 hypertensive patients with their family enrolled to receive regular salt (100 percent sodium chloride) for 3 months.
Sample size is 125 in each group (50 hypertensive + 75 individuals with normal blood pressure) which sums up to 250 individuals. The method is double blind randomized clinical trial.
Outcome measures include blood pressure, sodium & potassium in 24 h urine, attrition rate due to unacceptable taste of the salt.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130572N1
Registration date:2016-12-08, 1395/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 2357
Email address
mohammadi.mo@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
- Research Deputy of Tehran University of Medical Sciences
- Shournamak Yazd Company
Expected recruitment start date
2016-12-04, 1395/09/14
Expected recruitment end date
2017-03-17, 1395/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of a reduced-sodium, high-potassium salt substitute on hypertensive and normal population of Baharlou Clinic clients, Tehran, Iran at 2016-2017
Public title
The effects of a salt substitute on an Iranian population.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Age 25-65; Blood Pressure equal to or greater than 140 Systolic or 90 Diastolic in three measurements in two settings or consuming an anti-hypertensive drug; Cooperative with consuming salt for 3 months
Exclusion Criteria: Abnormal Serum Creatinine; Abnormal Serum Urea; Consuming medications: Digoxin, Lithium, K-Sparing Diuretics; Acute or Severe Cardiovascular Disease; Psychotic Disorders; Eating fast-foods or take-away foods or going to restaurant more than once a week
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Medicine Faculty, Tehran University of Medical Sciences
Street address
Building Number 1, Medicine Faculty, TUMS, Poursina St., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1118
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
Systolic Blood Pressure
Timepoint
First Day, End of Month1, End of Month2, End of Month3
Method of measurement
digital blood pressure monitor (3 measurements in each visit)
2
Description
Diastolic Blood Pressure
Timepoint
First Day, End of Month1, End of Month2, End of Month3
Method of measurement
digital blood pressure monitor (3 measurements in each visit)
3
Description
Sodium in 24 hour Urine collected
Timepoint
At first day and last day of the study
Method of measurement
24-h urine collection
4
Description
Potassium in 24 hour urine collection
Timepoint
At first day and last day of the study
Method of measurement
24-h urine collection
Secondary outcomes
1
Description
Attrition rate due to unacceptable salt taste
Timepoint
End of the study
Method of measurement
Attrition rate due to unacceptable salt taste in intervention group compared to control group
Intervention groups
1
Description
Intervention Group: Low sodium salt (80 percent sodium Chloride and 20 percent Potassium Chloride) for 3 months as the exclusive salt consumed
Category
Prevention
2
Description
Control Group: Regular Salt (100 percent sodium chloride) for 3 month as the exclusive salt consumed
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Preventive & Health Promoting Clinic, Baharlou Hospital
Full name of responsible person
Dr. Mohammad Mohammadi
Street address
Rah-Ahan Sq, Behdari St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Medicine Faculty, Tehran Universiy of Medical Sciences
Full name of responsible person
Ms. Khorrami
Street address
Building Number 1, Medicine Faculty, TUMS, Poursina Ave., Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Medicine Faculty, Tehran Universiy of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Shournamak Yazd Company
Full name of responsible person
Mr. Honaryar
Street address
37 Fakhr Razi St., Enqelab Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shournamak Yazd Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Community Medicine Department, TUMS
Full name of responsible person
Mohammad Mohammadi
Position
MD
Other areas of specialty/work
Street address
Community Medicine Department, Building number 4, TUMS, Poursina St., Kesharz Boulevard