Protocol summary

Summary
1- Introduction and background: It has been suggested that there is a relationship between vitamin D deficiency and glucose metabolism in type 2 diabetes. This association has not been studies in Iran so far. 2 – Objectives: we aimed to determine the effect of vitamin D on insulin resistance in patients with type 2 diabetes. The other aim was prevention of diabetes by supply vitamin D in serum. 3 – Design: randomized controlled double-blind clinical trial; the overall follow-up period was 3 month for each subject , they will be randomly divided into two groups of intervention and control 4 - Setting and conduct: At the start of study and after 90 days all patients will be evaluated for body mass index, waist to hip ratio, blood pressure, glycosylated hemoglobin, fasting blood sugar, triglyceride, insulin, homeostasis model assessment index and 25 - hydroxy vitamin D3. 5 - Inclusion criteria: treatment with oral hypoglycemic agents, optimal control: HbA1C (<7.5%) Exclusion criteria: gross deficiency vitamin D, renal failure, uncontrolled diabetes, daily intake of multivitamins, intake of oral vitamin D in the last month or injected in the past six months, uncontrolled hypertension 6 - The intervention group will receive one intramuscular injection of 300,000 international units of vitamin D3 and the control group will receive placebo. 7 - The main outcome (variables): 25 - hydroxy vitamin D3 level, glycemic status, insulin and homeostasis model assessment index will be compared in the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT1138901221414N12
Registration date: 2010-11-29, 1389/09/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-29, 1389/09/08
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2009-10-03, 1388/07/11
Expected recruitment end date
2010-10-03, 1389/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on insulin resistance of type 2 diabetic patients
Public title
Effect of vitamin D on insulin resistance in type 2 diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1- Good control HbA1C (< 7.5%) 2- Treatment with oral hypoglycemic agents Exclusion criteria: 1- Gross vitamin D deficiency 2- Renal failure, uncontrolled diabetes 3- Using daily multivitamine 4- Using oral vitamin D (one month prior to the study) or intravenous vit D in the 6 month period before the study 5- Uncontrolled hypertension
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Street address
North Karegar St., Dr.Sharati Hospital, 5th floor
City
Tehran
Postal code
Approval date
2009-10-02, 1388/07/10
Ethics committee reference number
E- 0098

Health conditions studied

1

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

Primary outcomes

1

Description
Insulin resistance
Timepoint
90 days
Method of measurement
Blood sample & measurement of fasting blood sugar and insulin in formula hemostasis model assessment index( fasting insulin based on microinternational unit per mililiter * fasting blood sugar based on miligram per desiliter / 405)

Secondary outcomes

1

Description
Glycemic status
Timepoint
90 days
Method of measurement
Blood sample

Intervention groups

1

Description
Intervention group: 1 cc ampule vitamin D 300000 IU at the beginning of the study
Category
Treatment - Drugs

2

Description
Control group: 1 cc placebo in control group at the beginning of the study
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Ozra Tabatabaei Malazy
Street address
North Karegar St., Dr. Sharati Hospital, 5th floor
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Heshmat
Street address
North karegar St., Dr.Shariati Hospital, 5th floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology & Metabolism Research Center of Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
ِDr.Kamran Moradzadeh
Position
Internist
Other areas of specialty/work
Street address
North Karegar St., Dr. Shariati Hospital, 5th floor
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
emrc@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Ozra Tabatabaei Malazy
Position
MD, MPH
Other areas of specialty/work
Street address
North karegar St., Dr.Shariati Hospital, 5th floor
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
otabatabaeimla@yahoo.com; tabatabaeiml@farabi.tums.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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