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Effect of vitamin D supplementation on insulin resistance and glycemic control in patients with diabetes type 2

Protocol summary

Summary
This double blind, randomized, placebo-controlled study will be performed with the aim of whether vitamin D supplementation can effect on insulin resistance and glycemic control in type 2 diabetic patients. 120 patients with diabetes type 2 according to these inclusion critera: ADA criteria 2011 and under treatment with oral hypoglycemic agents HbA1C<8.5%, patients with 21-60 of age, BMI>20 and exclusion critera of end stage diseases of organs such as ESRD,chronic liver disease, GFR<30ml/min,hypercalcemia and kidney stones, known primary hyperparathyroidism,consumption of vitamin D supplement over 400 IU within 2 months prior to intervention will be selected . initial testing of fasting blood glucose, 2 hours postprandial glucose, calcium, phosphorus, BUN, creatinine, HbA1C, 25 (OH) D and fasting serum insulin levels will be measured. 60 patients in the intervention group receivedVitamin D 50000 Units and 60 patients received placebo every two weeks. After 12 weeks (3 months) of intervention, fasting blood glucose, 2 hpp, HbA1C, fasting serum vitamin D levels will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012061110002N1
Registration date: 2013-03-25, 1392/01/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-03-25, 1392/01/05
Registrant information
Name
Monireh Bazdar
Name of organization / entity
Ahvaz Jondi Shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1722 9312
Email address
bazdar.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Ahvaz University of Medical Sciences, DiabetesR esearch Center
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-05-10, 1392/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on insulin resistance and glycemic control in patients with diabetes type 2
Public title
Effect of vitamin D supplementation on diabetes type 2
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion critera : 1) patients with diabetes type 2 according to ADA criteria 2011 and under treatment with oral hypoglycemic agents, 2) HbA1C ≤ 8.5%, 3) patients with 21-60 of age, 4) BMI>20 exclusion criteria : 1) end stage diseases of organs such as ESRD,chronic liver disease 2)GFR≤30ml/min, 3) hypercalcemia and kidney stones,4) known primary hyperparathyroidism,5) heart diseases included ischemic heart disease, heart failure,cardiomyopathy,6) sarcoidosis,7) TB ,8) cancer,9) history of IBD ,10) pregnancy,11) SBP/SDP≥175/104 mmHg ,12) consumption of vitamin D supplement over 400 IU within 2 months prior to intervention
Age
From 21 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Research and Technology Deputy, Research Ethics Committee
Street address
Ahvaz University City, Department of Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services
City
Ahvaz
Postal code
61357-15794
Approval date
2013-02-17, 1391/11/29
Ethics committee reference number
ETH-390

Health conditions studied

1

Description of health condition studied
Diabetes type 2
ICD-10 code
E-11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Insulin resistance and glycemic control (glucose*insulin/405)
Timepoint
just before and after 3 months of intervention
Method of measurement
alisun 3000 measure system

2

Description
HOMA-Beta
Timepoint
just before after 3 months of intervention
Method of measurement
glucose* insulin /405

3

Description
Hb A1C
Timepoint
just before after 3 months of intervention
Method of measurement
high performance liquid chromatography method using G8 TOSO Ssystem

4

Description
HOMA - IR
Timepoint
just before and 3 months after intervension
Method of measurement
insulin* 360 / glucose -63 %

Secondary outcomes

1

Description
Determination and comparison of the distribution of vitamin D (25 (OH) D) levels before and after treatment in both intervention and control groups
Timepoint
just before and after 3 months of intervention
Method of measurement
Chemiluminescence method using liusun system

Intervention groups

1

Description
placebo group will recieve placebo capsul made of hard jellatinous material as the same method as intervention group.
Category
Treatment - Drugs

2

Description
Intervention group will recieve 50000 IU vitamin D3 every 2 weeks for 3 months orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospial in Ahvaz City
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Teputy, Diabetes Research Center
Full name of responsible person
Dr.Mohammad Reza Abbass Pour; Director of Research Affairs
Street address
Ahwaz City University, Department of Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Teputy, Diabetes 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
Diabetes Research Center
Full name of responsible person
Dr.Homeyra Rashidi
Position
Research Assistant Diabetes Research Center
Other areas of specialty/work
Street address
Diabetes Research Center, Near the Information Center, Ahvaz Jondishapour Medical Sciences, University city, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1336 9539
Fax
Email
hrashidi2002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Diabetes Research Center
Full name of responsible person
Dr. Homeyra Rashidi
Position
Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Ahvaz, Azadegan street, Imam Khomeini hospital
City
Ahvaz
Postal code
Phone
00986112222086, 00986112220118
Fax
Email
hrashidi2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Monireh Bazdar
Position
Resident of Internal Medicine, MD
Other areas of specialty/work
Street address
Golestan Enghelab dormitories, Golestan boulevard, Ahvaz
City
Ahvaz
Postal code
Phone
Fax
Email
monireh.bazdar@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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