1,25 Dihydroxy vit D, increases production and secretion of several hormones, including insulin. The purpose of this study is to evaluate the effect of vitamin D supplementation on glycemic control of type 2 diabetic patients with vitamin D deficiency. Inclusion criteria include: a diagnosis of type 2 diabetes; HbA1c levels between 7-12% and serum vitamin D levels less than 30 ng / ml;
Exclusion criteria include: patients with a history of ESRD; every pregnant patient; the patient with a deficiency or inadequate vitamin D; any patient with nephrotic syndrome; history of present hypercalcemia and hyperparathyroidism, sarcoidosis; lung and bone malignancy. Among patients with 35-65 years and type 2 diabetes mellitus referred to Imam Khomeini Hospital of Ardabil, 100 patients randomly will be measured vitamin D levels. Those who have vitamin D deficiency, will be selected for a period of 12 weeks. We selected randomized clinical trial for 3 months. Fasting blood samples for analysis of baseline levels of fasting blood glucose, HbA1c, serum levels of calcium and vitamin Dand will be collected.blood pressure will be measured and Patients BMI will be calculated. Patients will be prescribed for 4 weeks, 4 capsules of vitamin D and 2 months, 2 capsules of vitamin D. After 3 months (end of study) values will be measured in these patients again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012520788N1
Registration date:2015-03-04, 1393/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-04, 1393/12/13
Registrant information
Name
Farid Pirouz
Name of organization / entity
Ardabil University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3326 1264
Email address
f.pirouz@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University Of Medical Sciences
Expected recruitment start date
2015-02-22, 1393/12/03
Expected recruitment end date
2015-03-08, 1393/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of the Effectiveness Of Vitamin D Supplementation On Glycemic Control In Type 2 Diabetic Patients With Vitamin D Deficiency
Public title
The Effect Of Vitamin D Supplementation On Glycemic Control In Diabetic Patients With Vitamin D Deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: A Diagnosis Of Type 2 Diabetes; HbA1c Levels Between 7-12%; Serum Vitamin D Levels Less Than 30 ng / ml Exclusion Criteria: Patients With A History Of ESRD; Every Pregnant Patient; The Patient With A Deficiency Or Inadequate Vitamin D; Any Patient With Nephrotic Syndrome; History Of Present Hypercalcemia And Hyperparathyroidism; Sarcoidosis; Lung And Bone Malignancy.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Medical University of Ardabil
Street address
Medical University of Ardabil
City
Ardabil
Postal code
5619853141
Approval date
2015-01-18, 1393/10/28
Ethics committee reference number
Arums.REC.93.57.
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
HbA1c
Timepoint
Before intervention, three months after the intervention.
Method of measurement
HPLC
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, three months after the intervention.
Method of measurement
Mm-Hg using a mercury sphygmomanometer
Intervention groups
1
Description
Vitamin D, Capsules 50 mg orally, 4 times a month and 2 times in 2 months after
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Emam Khomeini Hospital
Full name of responsible person
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical University of Ardabil
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Medical University of Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical University of Ardabil
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
Medical University of Ardabil
Full name of responsible person
Manouchehr Iranparvar MD
Position
Doctor Of Medicine
Other areas of specialty/work
Street address
Medical University of Ardabil
City
Ardabil
Postal code
5619853141
Phone
+98 45 3351 2006
Fax
Email
M.Iranparvar@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Ardabil
Full name of responsible person
Ahad Azami MD
Position
Doctor Of Medicine
Other areas of specialty/work
Street address
Medical University of Ardabil
City
Ardabil
Postal code
5619853141
Phone
+98 45 3351 2006
Fax
Email
A.Aazami@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farid Pirouz MD
Position
Resident Of Internal Medicine
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3326 1264
Fax
+98 45 3326 2140
Email
F777Pirouz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)