Objectives: Patients with end stage renal disease suffer from anemia and chronic renal failure is a risk factor for vitamin D deficiency. The aim of this study is to investigate the effect of vitamin D prescription on Erythropoietin requirement - anemia treatment drug- in vitamin D deficient patients.
Design: In this study 64 patients with end stage renal disease with at least 3 months hemodialysis will enter in study
Major Inclusion and Exclusion criteria: hemoglobin level less than 12g/dL and vitamin D level less than 30ng/dL but if their calcium level is more than 9.5mg/dL or phosphate level more than 5.5mg/dL or noncompliant patients will exclude from study.
Setting and conduct: In drug group (32 patients) they will receive pearl vitamin D, 50000 unit, manufactured by Zahravi company, for 12 weeks, weekly and then 3 weeks after that with cumulative dose 650000 units. In placebo group (32 patients) placebo pearl will give with the same route.
Main outcome measures : In the beginning, we will checke vitamin D level, hemoglobin, ferritin, calcium and albumin. In the end of month 2 and 4 we will checke vitamin D level, and other variables will checke monthly. We will evaluate Erythropoietin requirement weekly and will calculate cumulative dose of Erythropoietin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505152417N17
Registration date:2016-08-11, 1395/05/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-11, 1395/05/21
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D administration on treatment of anemia in ESRD patients with vitamin D deficiency on hemodialysis
Public title
The effect of vitamin D administration on treatment of anemia in ESRD patients with vitamin D deficiency on hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with renal failure on hemodialysis for 3 months at least; Patients with hemoglobin concentration Lower than 12 g/dl; Patients with vitamin D deficiency (25(OH) vit D < 30 ng/ml);
Exclusion criteria:
Patients with serum calcium level more than 9.5mg/dL; Patients with serum Phosphate level more than 5.5mg/dL; Non-compliant patients; Patients who were treated by medications that could affect their Hb level such as immunosuppressants.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
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 committee of "Vice Chancellor for Research, Isfahan University of Medical Sciences"
Street address
Hezar Jarib Ave.
City
Isfahan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
292280
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End Stage Renal Disease
Primary outcomes
1
Description
Serum 25 OH vitamin D level
Timepoint
At begining, end of 2 and 4 months
Method of measurement
ELISA, ng/mL
2
Description
Serum ferritin level
Timepoint
Monthly
Method of measurement
ELISA, mg/dL
3
Description
Serum Hemoglobin level
Timepoint
Monthly
Method of measurement
Cell counter, g/dL
4
Description
Erythropoietin dose requirement
Timepoint
Weekly
Method of measurement
Mathematically
Secondary outcomes
1
Description
Serum calcium level
Timepoint
Monthly
Method of measurement
ELISA, mg/dL
2
Description
Serum albumin level
Timepoint
Monthly
Method of measurement
ELISA, g/dL
3
Description
Serum adiponectin level
Timepoint
Begining and after 4 months
Method of measurement
ELISA
4
Description
Serum leptin level
Timepoint
Begining and after 4 months
Method of measurement
ELISA
5
Description
Serum ICAM level
Timepoint
Begining and after 4 months
Method of measurement
ELISA
6
Description
Serum VCAM level
Timepoint
Begining and after 4 months
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Pearl vitamin D 50000 IU, weekly for 12 weeks and after 3 weeks, manufactured by Zahravi company
Category
Treatment - Drugs
2
Description
Control group: Pearl placebo, weekly for 12 weeks and after 3 weeks, manufactured by Zahravi company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nour Hospital, Hemodialysis centre
Full name of responsible person
Dr. Afsoon Emami
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin Hospital, Hemodialysis center
Full name of responsible person
Dr. Zahraparin Hedayati
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Nephrologist
Other areas of specialty/work
Street address
Sofe street
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Afsoon Emami
Position
Proffessor of Nephrology
Other areas of specialty/work
Street address
Ostandari Street
City
Isfahan
Postal code
Phone
+98 31 3222 2127
Fax
Email
afsoon_emami@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
nephrologist
Other areas of specialty/work
Street address
Sofe street
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)