To study the effect of treatment with Vitamin D3 on Hemoglobin Levels in patients with ESRD undergoing hemodialysis and treatment with Erythropoietin
Design
Phase II randomized clinical trial, unblinded, 2 groups of 30 patients each for a total of 60 patients, followed for 12 weeks.
Settings and conduct
Vitamin D deficient patients undergoing Hemodialysis weekly and treated with erythropoietin, Referred to Sina and Imam Khomeini Hospitals in 2020 are divided between two groups. no blinding takes place.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients Undergoing Hemodialysis at least once weekly due to ESRD, Treatment with erythropoietin, Serum 25-hydroxy vitamin D content less than 30 nanograms/milliliter
Exclusion Criteria: Serum 25-hydroxy vitamin D content more than 30 nanograms/milliliter
Intervention groups
2 Intervention groups, One Undergoing treatment with 50000 IU Pearl Vitamin D3 once weekly, the other group Undergoes treatment with Calcium-Vitamin D3 500 mg Oral tablets three times a day, each for 12 weeks.
Main outcome variables
Serum Hemoglobin Levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042264N4
Registration date:2020-12-16, 1399/09/26
Registration timing:retrospective
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Ehsan Hedayatinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 3368
Email address
hedayatee.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-19, 1399/05/29
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-11-30, 1399/09/10
Scientific title
Evaluation of the effect of vitamin D deficiency treatment on hemoglobin levels in hemodialysis patients
Public title
Vitamin D Treatment in Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Undergoing Hemodialysis at least once weekly due to ESRD
Treatment with erythropoietin
Serum 25-hydroxy vitamin D content less than 30 nanograms/milliliter
Exclusion criteria:
Serum 25-hydroxy vitamin D content more than 30 nanograms/milliliter
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Using a Sequence Generator (freely available at www.random.org), A set of numbers from 1 to 60 was requested in two columns, the results were two columns of 30 Integers from one to 60, without repetition, which were used for division.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.AJUMS.REC.1399.288
Health conditions studied
1
Description of health condition studied
Anemia in patients with End Stage Kidney Disease (ESRD)
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum Hemoglobin level
Timepoint
before intervention, 3 months after intervention
Method of measurement
Complete Blood Count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group Undergoes treatment with 50000 IU Pearl Vitamin D3 once weekly for 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: This group Undergoes treatment with Calcium-Vitamin D3 500 mg Oral tablets three times a day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital
Full name of responsible person
Shahla Ahmadi Halili
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
ahmadihalili-sh@ajums.ac.ir
Web page address
https://himam.ajums.ac.ir/
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Shahla Ahmadi Halili
Street address
Sina Hospital, Imam Ali Square, Ayatollah Behbehani Highway, Karun
City
Karun
Province
Khouzestan
Postal code
1711161991
Phone
+98 61 1555 0591
Email
ahmadihalili-sh@ajums.ac.ir
Web page address
https://hsina.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellory of Research and Technology, Central Library, Daneshjou Square, Ahvaz Jundishpaur University of Medical Sciences, Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Web page address
https://vchresearch.ajums.ac.ir
Grant name
Evaluation of effect of vitamin D defieiency treatment on level of HB in Hemodialysis patients
Grant code / Reference number
CRD-9902
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
Shahla Ahmadi Halili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
ahmadihalili-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Ahmadi Halili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
ahmadihalili-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Ahmadi Halili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
ahmadihalili-sh@ajums.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