The effect of vitamin D administration on bone and inflammatory indexes in hemodialysis patients
Design
This study was a single center, randomized, double-blind, placebo-controlled trial performed Tabriz, Iran. Stable chronic hemodialysis patients attending the Imam Reza university hospital dialysis center were eligible for screening.
Settings and conduct
This study was a single center, randomized, double-blind, placebo-controlled trial performed Tabriz, Iran. Stable chronic hemodialysis patients attending the Imam Reza university hospital dialysis center were eligible for screening.
Participants/Inclusion and exclusion criteria
15-70 years hemodialysis more than 3 month 3 times per week vitamin D less than 30 ml/ng.
Intervention groups
1 allocation ratio into two groups to receive either 50,000 IU of cholecalciferol or placebo every week for 12 weeks.
Main outcome variables
administration on bone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190921044834N1
Registration date:2019-12-04, 1398/09/13
Registration timing:retrospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
hamid Tayyebikhosroshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3966
Email address
khosroshahih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D administration on bone and inflammatory indexes in hemodialysis patients
Public title
The effect of vitamin D administration on bone and inflammatory indexes in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
15-70 years
hemodialysis more than 3 month
3 times per week
vitamin D less than 30 ml/ng
Exclusion criteria:
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Use of aplication rand list 1/2
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5732457869
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.TBZMED.REC.1398.588
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
N00-N99
ICD-10 code description
بیماریهای سیستم ادراری تناسلی
Primary outcomes
1
Description
Administration on bone
Timepoint
In the start of study، 84 days
Method of measurement
Factors of labratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: allocation ratio into two groups to receive either 50,000 IU of cholecalciferol every week for 12 weeks.
Category
Placebo
2
Description
Control group: allocation ratio into two groups to receive either 50,000 IU of placebo every week for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Jalal etemadi
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5744325621
Phone
+98 41 3335 5921
Email
khosroshahih@TBZMED.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid tayyebi khosroshahi
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5974324466
Phone
+98 41 3335 5921
Email
khosroshahih@TBZMED.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamid tayyebi khosroshahi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5974324466
Phone
+98 41 3335 5921
Email
khosroshahih@TBZMED.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid tayyebi khosroshahi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5974324466
Phone
+98 41 3335 5921
Email
khosroshahih@TBZMED.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid tayyebi khosroshahi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences Street Gholghasht Street Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5974324466
Phone
+98 41 3335 5921
Email
khosroshahih@TBZMED.ac.ir
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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available