Protocol summary

Summary
This clinical trial is conducted on 60 patients who are certainly suffering from Type 2 Diabetes Mellitus and referred to Endocrinology Clinic of Shahr-e- Kord University of Medical Sciences. Among Type 2 diabetics referred to this clinic, the patients with one of the exclusion criteria are excluded from the study and the remaining patients are randomly divided into two 30-person groups. First, the level of 25OHD is measured in all patients so that Vitamin D status is specified in Type 2 diabetics in question, and then the first group shall be treated by edible Calcitriol, for 0.5 microgram per day during 12 weeks or Pearl Vitamin D and the second group shall be treated by Placebo during these 12 weeks. Prior to the study, all patients were tested by Fasting Blood Sugar (FBS), 2 hour post prandial glucose, and lipid profile including Total Cholesterol and Triglyceride, LDL-C, HDL-C, HbA1C, and 25OHD tests. After 12 weeks, the testing variables of Fasting Blood Sugar (FBS), 2 hour post prandial glucose, and lipid profile including Total Cholesterol and Triglyceride, LDL-C, HDL-C, HbA1C, and 25OHD tests will be repeated for both groups and both groups are compared with paired t-test. It is tried that all 60 selected patients are approximately placed in similar range in terms of diabetes control, diet and activity level.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011185191N6
Registration date: 2011-10-05, 1390/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-05, 1390/07/13
Registrant information
Name
Mohammad Saeed Behradmanesh
Name of organization / entity
Shahr-e-Kord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 4917
Email address
sbehradmanesh@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cellular Molecular Research Center
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of Vitamin D Supplement Effect on Improvement of Glycemic Indexes in Type 2 Diabetics
Public title
The Study of Vitamin D Supplement Effect on Improvement of Glycemic Indexes in Type 2 Diabetics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient's consent for participation in the study; Final diagnosis of Type 2 diabetes based on standard criteria; having no advanced nephrology and liver diseases as well as any other chronic diseases based on patient biography and clinical examination; having 0.7.5% ≥ HBA1C ≥ 7%. Exclusion criteria: Non-satisfaction of the patient for participation in the study; any chronic debilitive critical diseases based on patient biography and clinical examination; improper diabetes control HBA1C>7.5%; taking any calcium and vitamin D supplement during the last six months.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethic committee of Shahr-e-Kord University of Medical Sciences
Street address
Ayatollah kashani Blvd, Shahr-e-Kord University of Medical Sciences
City
Shahr-e-kord
Postal code
Approval date
2010-04-22, 1389/02/02
Ethics committee reference number
89-2-2

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Measure of glycosylated hemoglobin (HbA1c)
Timepoint
3 months
Method of measurement
Laboratory

2

Description
Fasting glucose levels
Timepoint
3 months
Method of measurement
Laboratory

3

Description
Glucose levels 2 hours after a meal
Timepoint
3 months
Method of measurement
Laboratory

4

Description
Total cholesterol and triglyceride levels and LDL-C and HDL-C
Timepoint
3 months
Method of measurement
Laboratory

Secondary outcomes

1

Description
Vitamin D level
Timepoint
3 months
Method of measurement
Laboratory

Intervention groups

1

Description
Daily half micrograms of calcitriol for 12 weeks
Category
Treatment - Drugs

2

Description
Placebo for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology Clinic
Full name of responsible person
Dr Kamran Roudini
Street address
City
Shahr-e-kord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cellular Molecular Research Center
Full name of responsible person
Ms Beheshteh Amiri
Street address
Ayatollah kashani Blvd
City
Shahr-e-Kord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cellular Molecular Research Center
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
Shahr-e-Kord University of Medical Sciences
Full name of responsible person
Dr Kamran Roudini
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Ayatollah kashani Blvd, Shahr-e-kord University of Medical Sciences
City
Shahr-e-Kord
Postal code
Phone
+98 38 1222 8262
Fax
Email
Roudini.k@gmail .com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahr-e-Kord University of Medical Sciences
Full name of responsible person
Dr Saeed Behradmanesh
Position
Endocrinologist
Other areas of specialty/work
Street address
Ayatollah kashani Blvd, Shahr-e-kord University of Medical Sciences
City
Shahr-e-kord
Postal code
Phone
+98 381225063
Fax
Email
sbehradmanesh@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Kamran Roudini
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Ayatollah Kashani Blvd.
City
Shahrekord
Postal code
Phone
Fax
Email
Roudini.k@gmail.com
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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