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IRCT20180127038521N1 IRCT 2018-04-02 Iran University of Medical Sciences The Effect of Vitamin D and Synbiotic Supplementation in Type 1 Diabetes. The effects of vitamin D and synbiotic co-supplementation on HbA1c, Metabolic Profile, Serum Concentration of some biomarkers of inflammation, oxidative stress and quality of life in patients with type 1 diabetes 2018-03-06 anticipated 114 Complete https://irct.ir/trial/29218 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For Randomization, the Permuted Block Randomization Method will be Used Blocks with the Size of Four . According to the Sample Size 114, 29 Blocks will be Produced Using the Online Site (www.sealedenvelope .com), Blinding description: In order to Apply Concealment in the Randomization Process, Unique Codes which are Generated by the Software will be Used on the Supplements Box., By Entering each Person into the Study According to the Generated Sequence, the Supplement Box where the Code is Registered on will be Assigned to the Individual. During the Study, the Randomization List is Provided to the Statistic Consultant and the Participants, the Project Author and all those who Participate in the Measurement of the Indices will not be Informed of the Assigned Groups. 3 Type 1 Diabetes. 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 One Capsule of Synbiotic (Manufactured by Zisttakhmir Company) Per Day (Containing probiotic species Lactobacillus Casei, Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium Bro, Bifidobacterium Longum, Streptococcus Thermophilus CFU / gr1010 and Fructo-Oligosaccharide (38.5 mg)) During the 3 Months of Intervention. In order to Maintain Cooling Chain, each Patient is Provided with an Ice Bag for Carrying Synbiotic Supplementation. Intervention 2: Control group: The Intervention Duration will be 3 Months. Individuals in the Control Group will Receive Vitamin D Pelacebo (Manufactured by Zahravi Company) every 2 weeks . Vitamin D Pelacebo Contains Lactose. They will also Receive 1 Synbiotic Placebo per day for 12 weeks (Manufactured by Zisttakhmir Company). Synbiotic Placebo Contains Lactose, Magnesium Stearate, Talc, Silicon Dioxide. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is No more Information
public Fatemeh-Sadat Amiri
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4818 amiri.fs@iums.ac.ir Iran University of Medical Sciences scientific Fatemeh-Sadat Amiri
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 amiri.fs@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 65 years Both 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 E10 Type 1 diabetes mellitus Treatment - Other Placebo 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 One Capsule of Synbiotic (Manufactured by Zisttakhmir Company) Per Day (Containing probiotic species Lactobacillus Casei, Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium Bro, Bifidobacterium Longum, Streptococcus Thermophilus CFU / gr1010 and Fructo-Oligosaccharide (38.5 mg)) During the 3 Months of Intervention. In order to Maintain Cooling Chain, each Patient is Provided with an Ice Bag for Carrying Synbiotic Supplementation. Control group: The Intervention Duration will be 3 Months. Individuals in the Control Group will Receive Vitamin D Pelacebo (Manufactured by Zahravi Company) every 2 weeks . Vitamin D Pelacebo Contains Lactose. They will also Receive 1 Synbiotic Placebo per day for 12 weeks (Manufactured by Zisttakhmir Company). Synbiotic Placebo Contains Lactose, Magnesium Stearate, Talc, Silicon Dioxide. 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 α. 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. 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: Measuring Tape. Bloating condition. Timepoint: Before and After Intervention. Method of measurement: Questionnaire. Body fat percentage. Timepoint: Before and After Intervention. Method of measurement: inbody scale. Iran University of Medical Sciences Approved 2017-10-27 Ethics committee of Iran University of Medical Sciences Tehran, Hemat Highway, Next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)