Evaluating the effect of vitamin D on decreasing blood pressure in patients with Stage 1 hypertension
Design
Randomized clinical trial, without control group, parallel groups, double-blind, phase 2, 80 patients, randomization with rand function of Excel software.
Settings and conduct
This study will be performed on patients with stage 1 blood pressure and vitamin D deficiency referred to the Golestan Hospital nephrology clinic and patients will be given 2 different doses of vitamin D in two treatment groups.In this randomization, none of the patients in the two groups and the physician will know the type and dosage of the prescribed drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: serum level vitamin D between 10-30 ng/dl; having hypertension stage 1. Exclusion criteria: CKD> 1.2 mg / dL; Liver failure; Proteinuria greater than 500 mg in 24 hours; heart failure; Pregnancy; Secondary hypertension; No consumption more than 20% of the drug delivered to them.
Intervention groups
Patients in group A were given vitamin D at a dose of 1000 mg daily for 8 weeks. Vitamin D was manufactured by Sobhan Company from Iran. Group B was given vitamin D at a dose of 50,000 mg once a week for 8 weeks. The drugs were administered in both groups with 50 cc of water one hour before meals. Patients were also advised to follow a regular diet during the study period
Main outcome variables
Vitamin D levels and hypertension stage 1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042238N1
Registration date:2020-07-25, 1399/05/04
Registration timing:retrospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
reza zargoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4269 0075
Email address
drrezazargoosh78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
2019-11-11, 1398/08/20
Actual recruitment end date
2020-02-09, 1398/11/20
Trial completion date
2020-02-17, 1398/11/28
Scientific title
Evaluating the effect of vitamin D on decreasing blood pressure in patients with Stage 1 hypertension
Public title
effect of vitamin D on decreasing blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
serum level vitamin D between 10-30 ng/dl
having hypertension stage 1
Exclusion criteria:
CKD> 1.2 mg / dL
Liver failure patients
Proteinuria greater than 500 mg in 24 hours
Patients with heart failure
Pregnancy
Secondary hypertension
No consumption more than 20% of the drug delivered to them
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the interventionist and the person examining the results did not know what group the individuals were in, and the study would be double blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS)
Street address
Khuzestan Province, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-11-10, 1398/08/19
Ethics committee reference number
IR.AJUMS.REC.1398.580
Health conditions studied
1
Description of health condition studied
hypertension and vitamin D deficiency
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
Primary outcomes
1
Description
Hypertension
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
24-hour blood pressure monitoring and measurement
Secondary outcomes
1
Description
Measurement of vitamin d
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Through a laboratory test
Intervention groups
1
Description
Patients in group A vitamin D at a dose of 1000 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group: To group B, vitamin D with a dose of 50,000 mg per week for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Clinic of Golestan Hospital in Ahvaz
Full name of responsible person
Dr Eisa Rezaei
Street address
Ahvaz, Farvardin Blvd., Golestan hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Golestanjpsital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Eisa Rezaei
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Info@Ajums.Ac.Ir
Grant name
Ahvaz Jundishapur University of Medical Sciences
Grant code / Reference number
U-98172
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Eisa Rezaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Drrezazargoosh78@Gmail.Com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Eisa Rezaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Drrezazargoosh78@Gmail.Com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Eisa Rezaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Drrezazargoosh78@Gmail.Com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available