Protocol summary

Summary
217 patients (137 female, 80 male) having diabetes type 2 and age between 20 and 60 years old referred to diabetes Arak clinic were recruited. Inclusion criteria: Absence of hepatic, renal, bone disease, Not receiving anticonvulsant drugs, calcium, anticancer drugs and vitamin D. All of them were examined and information on their age, weight, PTH level, vit D level, BMI, renal and hepatic function tests, lipid profile, FBS, insulin, Ca, P, ALP, albumin, job, income, nutrition, and HOMA-IR were collected. Those with vit deficiency were categorised into three groups: mild deficiency: 20-25 ng/ml of 25-hydroxy vitamin D; moderate deficiency: 10-20 ng/ml of 25-hydroxy vitamin D; sever deficiency: 5-10 ng/ml of 25-hydroxy vitamin D. Patients were then given vit D 50000 units daily for 4 weeks. Their FBS and HoMA-IR were measured and compared before and after intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811073216N1
Registration date: 2010-08-25, 1389/06/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-08-25, 1389/06/03
Registrant information
Name
Afsaneh Talaiei
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 5229
Email address
talaiei.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2008-12-31, 1387/10/11
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D on insulin resistance in type two diabetic patients
Public title
Effects of vitamin D on insulin resistance in type two diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Absence of hepatic, renal, bone disease, Not receiving anticonvulsant drugs, calcium, anticancer drugs and vitamin D
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 217
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak university
Street address
Arak medical university
City
Arak
Postal code
Approval date
empty
Ethics committee reference number
5157

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10, E11.,
ICD-10 code description
Diabetes

Primary outcomes

1

Description
Insulin resistance
Timepoint
Immediately befor intervention and 1 Month after intervention
Method of measurement
HOMA-IR with Blood glucose and Insulin

Secondary outcomes

1

Description
Fasting Blood Sugar
Timepoint
1 month
Method of measurement
Laboratory methods

Intervention groups

1

Description
vit D tab 50000 unit oral one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak cilinic diabetes
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Dr Ashtiani
Street address
Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university
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
Arak medical university
Full name of responsible person
Dr Talaei
Position
Endocrinologist
Other areas of specialty/work
Street address
Arak
City
Arak
Postal code
Phone
+98 86 1222 5229
Fax
Email
talaiei.a@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak medical university
Full name of responsible person
ِDr Talaei
Position
Endocrinologist
Other areas of specialty/work
Street address
Arak
City
Arak
Postal code
Phone
+98 86 1222 5229
Fax
Email
talaiei.a@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak medical university
Full name of responsible person
Dr Talaeiِ
Position
Endocrinologist
Other areas of specialty/work
Street address
Arak
City
Arak
Postal code
Phone
+98 86 1222 5229
Fax
Email
talaiei.a2arakmu.ac.ir
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
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