The Effect of Vitamin D and Synbiotic Supplementation in Type 1 Diabetes.

Phase 3

Recruiting

• Conditions: Type 1 diabetes mellitus; Type 1 Diabetes.

• Registration Number: IRCT20180127038521N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 114

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.