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IRCT20190505043480N1 IRCT 2019-06-23 Kashan University of Medical Sciences Effect of Vitamin D on Blood Glucose Control The effect of vitamin D deficiency treatment on control of blood glucose in type 2 diabetic patients 2019-05-13 anticipated 80 Complete https://irct.ir/trial/39356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Condition 1: Diabetes. Condition 2: Vitamin D deficiency. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: After reading the data about the study outcomes after unidentifiable individuals are shared. When: After printing results To whom: For researchers working in academic and scientific institutions Conditions: For use in scientific papers and continuing scientific work in this field Where to obtain: 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 How to obtain: At the request of the Department of Science and Research of Kashan University of Medical Sciences Comments:
public Hajmoradi Hamed
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 0026 hajmoradi-h@kaums.ac.ir Kashan University of Medical Sciences scientific Mozaffari Majid
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 hajmoradi-h@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 30 years 85 years Both 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 E11.00 E55 Type 2 diabetes mellitus Vitamin D deficiency Treatment - Drugs Placebo 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. 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. Glycosylated hemoglobin(HbA1c). Timepoint: Before starting the study and 12 weeks after starting vitamin D. Method of measurement: Laboratory. Vitamin D levels. Timepoint: Before starting the study and 12 weeks after starting vitamin D. Method of measurement: Laboratory. Changes in level of liver enzymes(AST-ALT-ALK). Timepoint: Before the study began and 12 weeks later. Method of measurement: laboratory. Changes in lipid profiles (LDL-HDL-TG). Timepoint: Before the study began and 12 weeks later. Method of measurement: laboratory. Renal Profile Changes (BUN-Creatinine). Timepoint: Before the study began and 12 weeks later. Method of measurement: laboratory. Kashan University of Medical Sciences Approved 2019-05-06 Ethinic committee of kashan University of Medical sciences 5th of Qotb –e Ravandi Blvd. , Kashan, IRAN Kashan Isfehan Iran (Islamic Republic of)