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The effect of vitamin D deficiency treatment on control of blood glucose in type 2 diabetic patients

Protocol summary

Study aim
The effect of vitamin D deficiency on blood glucose control in type II diabetic patients
Design
This study was a double-blind clinical trial with control and control group randomly divided into two groups of 40 with 6 blocks. The first group was treated with vitamin D at 50,000 units per week for 12 weeks. And the second group will receive the placebo in these 12 weeks.
Settings and conduct
This study was done in different countries and cities of Iran. This study was conducted in Kashan and in diabetic patients referring to the clinic of Kashan Beheshti Hospital. In this study all patients are blinded and assured in the end of the study is decided according to their lab tests on how to continue their treatment. A laboratory partner who performs blood sampling also only knows the patients with the name of the researcher. The practitioner will not be advised in the treatment and how to choose patients.
Participants/Inclusion and exclusion criteria
Passed over 2 years after diagnosis of type 2 diabetes. Detection of Type 2 diabetes according to standard criteria HbA1C criteria range from 8-7 Fasting blood sugar is less than 200 Taking oral hypoglycemic drugs The level of vitamin D is between 10-19.9 Desire to cooperate in designing and completing a written questionnaire Lack of severe underlying disease causing a patient's disability or vitamin D metastable.
Intervention groups
This study will be done on 80 patients diagnosed with type 2 diabetes mellitus. Vitamin D levels are measured in patients and patients with vitamin D levels 10-19.9 are selected and randomly divided into six groups of 40 with six blocks, the first group with vitamin D at 50,000 units per week for 12 weeks are treated and the second group will receive the placebo in these 12 weeks.
Main outcome variables
Age؛ Gender؛ Vit D treatment؛ Duration of diabetes؛ ؛ FBS Cr؛ TG CHO ؛ LDL ؛ HDL and HbA1C

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190505043480N1
Registration date: 2019-06-23, 1398/04/02
Registration timing: retrospective

Last update: 2019-06-23, 1398/04/02
Update count: 0
Registration date
2019-06-23, 1398/04/02
Registrant information
Name
Hamed Hajmoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
hajmoradi-h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-13, 1398/02/23
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D deficiency treatment on control of blood glucose in type 2 diabetic patients
Public title
Effect of Vitamin D on Blood Glucose Control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
It's been over 2 years since the diagnosis of type 2 diabetes Detection of Type 2 diabetes according to standard criteria HbA1C criteria range from 8-7 Fasting Blood glucose under 200 Using of oral Glucose-lowering Agents Not taking vitamin D and calcium supplements at least 3 months ago, not taking medications that affect vitamin D metabolism (corticosteroids, calcitonin, cytotoxic drugs and immunosuppressive drugs, anticonvulsants) at least 3 months ago, lack of diseases that affect the metabolism of vitamins D effects (such as liver, endocrine, and cancer) Desire to cooperate in designing and completing a written questionnaire he level of vitamin D is between 10 and 19.9 Age between 30-85
Exclusion criteria:
Malnutrition, Infertility, Oligomenorrhea, Pregnancy, Breastfeeding, Malignancy Smoking, alcohol consumption Immobilization for more than a week Acute and chronic active infections, acute and chronic inflammatory diseases, cardiovascular, liver, kidney, thyroid and parathyroid disorders
Age
From 30 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
This double-blind, randomized clinical trial is conducted on 80 patients diagnosed with type 2 diabetes mellitus and referred to the clinic of Kashan's Shahid Beheshti Hospital in 1398. Eligible patients are selected according to entry and exit criteria and after receiving a complete explanation of the study plan, they will receive written consent. Demographic and anthropometric characteristics of the patients will be recorded according to the individual questionnaire including age, sex, height, weight and duration of diabetes. The level of vitamin D in patients is then measured and patients with vitamin D 10-19.9 will be selected and randomly divided into six groups of 40 with 6 blocks, the first group with vitamin D of 50,000 IU They are treated weekly for 12 weeks, and the second group receives placebo in these 12 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are fully relied on how to study, and they are assured that at the end of the 12 weeks, according to the lab tests, they will decide on how to continue their treatment. The clinical practitioners are laboratory personnel who Obtaining samples has been selected and they are only collected through the introduction of a letter with a completely identical text that I am giving it to patients and referring to the laboratory. The data analyst is also a third-party epidemiologist who does not know how to do the work.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethinic committee of kashan University of Medical sciences
Street address
5th of Qotb –e Ravandi Blvd. , Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.019

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11.00
ICD-10 code description
Type 2 diabetes mellitus

2

Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency

Primary outcomes

1

Description
Glycosylated hemoglobin(HbA1c)
Timepoint
Before starting the study and 12 weeks after starting vitamin D
Method of measurement
Laboratory

2

Description
Vitamin D levels
Timepoint
Before starting the study and 12 weeks after starting vitamin D
Method of measurement
Laboratory

Secondary outcomes

1

Description
Changes in level of liver enzymes(AST-ALT-ALK)
Timepoint
Before the study began and 12 weeks later
Method of measurement
laboratory

2

Description
Changes in lipid profiles (LDL-HDL-TG)
Timepoint
Before the study began and 12 weeks later
Method of measurement
laboratory

3

Description
Renal Profile Changes (BUN-Creatinine)
Timepoint
Before the study began and 12 weeks later
Method of measurement
laboratory

Intervention groups

1

Description
Intervention group: In this group patients will be treated by oral 50000 IU vitamin D3 capsule(cholecalciferil), once every week for 12 weeks. The capsule manufacture in Zahravi pharmaceutical co.
Category
Treatment - Drugs

2

Description
Control group: In this group, patients with oral placebo capsules similar to the Vitamin D capsule of 50,000 IU, made by Barij Essens co, packaged in the similare blister package, will be treated for once weekly, for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology Clinic, Kashan Shahid Beheshti Hospital
Full name of responsible person
Hajmoradi Hamed
Street address
5th of Qotb –e Ravandi Blvd Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
hajmoradi-h@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Banafshe
Street address
5th of Qotb –e Ravandi Blvd, Kashan University of Medical sciences, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Fax
+98 31 5554 8900
Email
banafsheh_h@kaums.ac.ir
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hajmoradi Hamed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0026
Email
hajmoradi-h@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mozaffari Majid
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
hajmoradi-h@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hajmoradi Hamed
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
hajmoradi-h@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After reading the data about the study outcomes after unidentifiable individuals are shared.
When the data will become available and for how long
After printing results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in scientific papers and continuing scientific work in this field
From where data/document is obtainable
Data collection will be possible in coordination with the Department of Science and Research of Kashan University of Medical Sciences. www.medicine.kaums.ac.ir
What processes are involved for a request to access data/document
At the request of the Department of Science and Research of Kashan University of Medical Sciences
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