Type 1 Diabetes. Type 1 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: The Duration of the Intervention will be 3 Months. the Intervention Group will be given one Vitamin D 50,000 IU (Manufactured by Zahravi Company)every 2 weeks and
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Desire to cooperate and sign a written informed consent HbA1c more than 7% (Based on the American Diabetes Association's Guidelines to Uncontrolled Diabetes) Duration of the Disease more than 1 Year Treatment with Multiple Injections of Insulin (Regular, NPH, Glargine, Detemir, Aspartate, Glulosin, Lispro)
Exclusion criteria
Exclusion criteria: Pregnancy autoimmune disorders (celiac, hashimato, asthma, allergies, ..) Severe Hypoglycemia so that the Person Needs Another Person's Help to Resolve the Condition (3 Times or more During the Last Year, 1 or more in the Last 3 Months) Hyperglycemia Leads to Ketoacidosis over the Past Month Use of Mixed Insulin (Novomix and 70/30) taking vitamin D supplements (oral and Injection) taking synbiotic supplement taking calcium-vitamin D taking multivitamin-minerals taking antioxidant or anti-inflammatory such as vitamins E and C supplements, omega-3 fatty acids taking Consumption of Vitamin D-Enriched Foods over the Past 3 Months Severe Complications of Diabetes (Advanced Macrovascular and Microvascular Complications Including Major Cardiovascular Disorders (Acute Myocardial Infarction, Coronary Artery Bypass, Stroke and Peripheral Arterial Disease), Severe Nephropathy) cancer hepatic failure end-stage renal disease stroke with cognitive deficiency psychotic disorder bipolar disorder severe substance abuse mental retardation active infection rheumatoid arthritis inflammatory bowel disease Special Medicines (Hormone Therapy) Taking psychotropic drugs taking immunosuppressive medications over the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c. Timepoint: Before and After Intervention. Method of measurement: Biochemical Test.;Serum Level of 25 Hydroxyvitamin D. Timepoint: Before and After Intervention. Method of measurement: Biochemical Test.;Total Insulin Demand. Timepoint: Before and After Intervention. Method of measurement: Questionnaire.;High Sensitivity C-Reactive Protein. Timepoint: Before and After Intervention. Method of measurement: Chemiluminescence.;Tumour Necrosis Factor a. Timepoint: Before and After Intervention. Method of measurement: ELISA.;Total Antioxidant Capacity. Timepoint: Before and After Intervention. Method of measurement: Colorimetric.;Malondialdehyde. Timepoint: Before and After Intervention. Method of measurement: Colorimetric. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose. Timepoint: Before and After Intervention. Method of measurement: Biochemical Test.;Triglyceride. Timepoint: Before and After Intervention. Method of measurement: Photometric.;Total Cholesterol. Timepoint: Before and After Intervention. Method of measurement: Photometric.;HDL-Cholesterol. Timepoint: Before and After Intervention. Method of measurement: Enzymatic Method.;LDL-Cholesterol. Timepoint: Before and After Intervention. Method of measurement: Enzymatic Method.;Systolic Blood Pressure. Timepoint: Before and After Intervention. Method of measurement: Mercuric Barometer.;Diastolic Blood Pressure. Timepoint: Before and After Intervention. Method of measurement: Mercuric Barometer.;Interleukin 17. Timepoint: Before and After Intervention. Method of measurement: ELISA.;Insulin Resistance. Timepoint: Before and After Intervention. Method of measurement: Estimated Glucose Disposal Rate.;Weight. Timepoint: Before and After Intervention. Method of measurement: scale.;Body Mass Index. Timepoint: Before and After Intervention. Method of measurement: Calculation.;Waist Circumference. Timepoint: Before and After Intervention. Method of measurement: Measuring Tape.;Waist / Hip Ratio. Timepoint: Before and After Intervention. Method of measurement: Calculation.;Injected Insulin Dose. Timepoint: Before and After Intervention. Method of measurement: Questionnaire.;Number of Insulin Injections. Timepoint: Before and After Intervention. Method of measurement: Questionnaire.;Hand Grip. Timepoint: Before and After Intervention. Method of measurement: Dynamometer.;Quality-of-Life. Timepoint: Before and After Intervention. Method of measurement: Questionnaire Quality-of-Life.;Mood. Timepoint: Before and After Intervention. Method of measurement: Questionnaire Beck Depression.;Mean Arterial Pressure. Timepoint: Before and After Intervention. Method of measurement: Calculation.;Hip circumference. Timepoint: Before and After Intervention. Method of measurement: M | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh-Sadat Amiri
Iran University of Medical Sciences
Outcome results
None listed