the effect of vitamin K supplementation on bone factors in hemodialysis patients
Comparison of alkaline phosphatase level in hemodialysis patients in two groups A and B
Comparison of calcium level in hemodialysis patients in two groups A and B
Comparison of phosphorus level in hemodialysis patients in two groups A and B
Comparison of vitamin D level in hemodialysis patients in two groups A and B
Design
A clinical trial with a control group with parallel groups, randomized using a phase 2-3 randomized block method on 72 patients with ESRD and hemodialysis. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted by randomized block method on ESRD patients hemodialysis referred to 5 Azar and Yad Gorgan Hospital in 2021.
Participants/Inclusion and exclusion criteria
Hemodialysis patients with the age of 18-75 years and at least one month has passed since the start of dialysis are included in the study, and at the same time, patients with the use of anticoagulant drugs, antibiotics, infection with high CRP and lack of satisfaction and non-compliance with medication The study will be deleted.
Intervention groups
Group A: Calcium-D capsule with vitamin K2 tablet (capsule containing vitamin K2-7, microcrystalline, cellulose, colloidal silicon dioxide, magnesium stearate)
Group B: calcium capsule - D
Main outcome variables
The main outcome of the study:Changes of the average serum alkaline phosphatase level after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221217056845N1
Registration date:2023-03-04, 1401/12/13
Registration timing:retrospective
Last update:2023-03-04, 1401/12/13
Update count:0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
sedighe maghsoudloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3246 0722
Email address
roya_sissy200@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin K supplementation on bone factors in hemodialysis patients
Public title
the effect of vitamin K supplementation on bone factors in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not using anticoagulant drugs
age 18-75 years
patient with ESRD and hemodialysis
patients that dialyses > 1 months.
Exclusion criteria:
Coagulation disorder
Lack of consent to study
Hypocalcemia or hypercalcemia in patients
Infection before and during treatment with High CRP
Using of antibiotic drugs
Using of osteoporosis drugs
lack of medication compliance
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were assigned to experimental and control groups using the random block method. For random allocation using blocks of 4, first by throwing 18 regular hexagons, a random sequence of 18 blocks of 4 was generated from among the following blocks:
AABB-ABAB-ABBA-BAAB-BABA-BBAA
In the desired sequence, there will be 37 of each letter A and B. According to the above block, 72 envelopes were prepared and the letter A or B was placed in each envelope and numbered from 1 to 72.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Vice President of Research,Gorgan University of Medical Sciences, the beginning of Shesat Kala Rural Road,Hirkan Blvd,Basij Square
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ - ۴۹۳۴۱
Approval date
2022-12-16, 1401/09/25
Ethics committee reference number
IR.GOUMS.REC.1401.21
Health conditions studied
1
Description of health condition studied
Patients with ESRD undergoing hemodialysis
ICD-10 code
I12.0
ICD-10 code description
Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease
Primary outcomes
1
Description
Comparison of the average serum levels of albumin after the implementation of the intervention
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
2
Description
Comparison of the average serum levels of calcium after the implementation of the intervention
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
3
Description
Comparison of the average serum levels of phosphorus after the implementation of the intervention
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
4
Description
Comparison of the average serum levels of Vitamin D after the implementation of the intervention
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
Secondary outcomes
1
Description
Comparison of the mean serum PTH level after the implementation of the intervention to the basic value
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
2
Description
Comparison of the mean serum alkaline phosphatase (AKP) level after the implementation of the intervention to the basic value
Timepoint
At the beginning of the study and 3 month later
Method of measurement
blood sample
Intervention groups
1
Description
Intervention group: Calcium-D capsule (Shefa company contains 500 mg calcium and 200 IU vitamin D) along with vitamin K2 tablets (capsule containing vitamin K2-7, microcrystalline, cellulose, colloidal silicon dioxide, magnesium stearate) three times in daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: They receive calcium-D capsules three times a day for 8 weeks and placebo tablets with the same packaging and shape as vitamin K2 capsules.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Dr Saeid Amirkhanlou
Street address
Fifth Azar Hospital, Valiasr Square, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174523
Phone
+98 17 3222 0561
Email
drsam74ir@ymail.com
2
Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Dr Saeid Amirkhanlou
Street address
Sayad Shirazi Hospital, Bahnar Square
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3226 1150
Email
Sayyadlib@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza honarvar
Street address
Gorgan University of Medical Sciences,the beginning of Shasta Kala Rural Road, Hirkan Blvd, Basij Square.
City
Gorgan
Province
Golestan
Postal code
۴۹۳۴۱۷۴۵۱۵
Phone
+98 17 3245 0021
Email
gsm@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Sedighe Maghsoudloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahman Alley 5,Saqai Alley 6,Afsaran Blvd,AfsaranTown, Gorgan City
City
Gorgan
Province
Golestan
Postal code
49178677439
Phone
+98 17 3246 0722
Fax
Email
roya_sissy200@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sedighe Maghsoudloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahman Alley 5,Saqai Alley 6,Afsaran Blvd,AfsaranTown, Gorgan City
City
Gorgan
Province
Golestan
Postal code
49178677439
Phone
+98 17 3246 0722
Fax
Email
roya_sissy200@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sedighe Maghsoudloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahman Alley 5,Saqai Alley 6,Afsaran Blvd,AfsaranTown, Gorgan City
City
Gorgan
Province
Golestan
Postal code
49178677439
Phone
+98 17 3246 0722
Fax
Email
roya_sissy200@yahoo.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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The level of variables before and after the study / age of the patient / duration of dialysis and sex are informed
When the data will become available and for how long
Start the access period 6 months after printing results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
request and submission of usage documentation in new studies
From where data/document is obtainable
Golestan University of Medical Sciences / Gorgan - Hirkan Blvd - Golestan University of Medical Sciences / 01732430310 / pr-5azar@goums.ac.ir
What processes are involved for a request to access data/document