1. Home
  2. Approved trials
  3. » فارسی

Effectiveness of oral administration of vitamin D in anemia of patients with type 2 diabetes with mild renal impairment

Protocol summary

Summary
Objective of this study is evaluation of effectiveness of oral administration of vitamin D in anemia of patients with type 2 diabetes with mild renal impairment. This study is a Phase II clinical trial, triple blind, single-center study. All patients with type 2 diabetes and anemia (Hb <12 for females and Hb,13 for males) who were referred to Imam Ali hospital clinics and their serum vitamin D levels are lower than 30 ng / ml are considered. The patients in stage 1 renal impairment with normal serum iron, ferritin, retic, LDH, ESR, TIBC, erythropoietin and unexplained anemia, after applying exclusion criteria are included. All participants provided informed consent. Patients were randomly assigned in two groups ( 50 patients in case group and 50 patients in control group). In case group, patients receiving vitamin D 50000 unit per week for 8 weeks and in control group patients receiving placebo for 8 weeks Finally, the hemoglobin, hematocrit levels and vitamin D for each patient was recorded at the end of the second month of treatment and outcomes of the two groups will be compared.

General information

Acronym
Effectiveness of oral administration of vitamin D in anemia of patients with type 2 diabetes with m
IRCT registration information
IRCT registration number: IRCT2016011125951N1
Registration date: 2016-06-14, 1395/03/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
seyed mehdi hashemi
Name of organization / entity
zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 6343
Email address
hashemimahdi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, zahedan university of medical sciences
Expected recruitment start date
2016-03-25, 1395/01/06
Expected recruitment end date
2017-03-26, 1396/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral administration of vitamin D in anemia of patients with type 2 diabetes with mild renal impairment
Public title
Effectiveness of oral administration of vitamin D in anemia of patients with type 2 diabetes with mild renal impairment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :all diabetic cases with anemia based on WHO criteria and mild renal impairment according to Staging ( KDIGO 2012 exclusion criteria:history of transfusion during 3 months ago/history of recent bleeding/history of recent infection during 2 months ago/history of supplement therapy/pregnancy/smoking/chronic disease of liver/kidney hypercalcemia/hyperparathyroidesim/explained anemia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization ( Table of random numbers)

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zhedan university of medical sciencesDr hesabi square, Zahedanm, Iran
City
Zahedan
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
IR.ZAUMS.REC.1394.333

Health conditions studied

1

Description of health condition studied
anemia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemoglobin and vitamin D before intervention and 8 weeks after interventin
Timepoint
before intervention and at the end of intervention ( end of second month)
Method of measurement
enzyme immunoassay method (EIA) [immunodiagnostic system; IDS (LTD), UK].

Secondary outcomes

1

Description
Srum 25 hydroxy vitamin D
Timepoint
8 WEEKS
Method of measurement
enzyme immunoassay method (EIA)

Intervention groups

1

Description
intervention group: 50 patients in this group receiving 50000 unit per week (pearl, Manufacturing Co. Zahravi) for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: 50 patients in placebo group receiving placebo (pearl, Manufacturing Co. Zahravi) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
zahedan university of medical sciences
Full name of responsible person
Mahdi Hashemi
Street address
City
zahedan

2

Recruitment center
Name of recruitment center
ali ebn e abitaleb hospital
Full name of responsible person
dr seyed mahdi hashemi
Street address
ali ebn e abitaleb hospital
City
zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Houshang rafighdoust
Street address
Dr Hesabi square, zahedan university of medical sciences
City
zahedan
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 of Zahedan 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
seyed mehdi hashemi
Full name of responsible person
seyed mehdi hashemi
Position
zahedan university of medical sciences
Other areas of specialty/work
Street address
hematologist and medical oncologist
City
zahedan university of medical sciences
Postal code
Phone
+98 54 3342 6343
Fax
Email
hashemimahdi@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
seyed mehdi hashemi
Full name of responsible person
seyed mehdi hashemi
Position
hematologist and medical oncologist
Other areas of specialty/work
Street address
zahedan university of medical sciences
City
zahedan
Postal code
Phone
+98 54 3342 6343
Fax
Email
اhashemimahdi@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
seyed mehdi hashemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...