Protocol summary
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Study aim
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The effects of vitamin D and synbiotic co-supplementation on HbA1c, Metabolic Profile and Serum Concentration of some biomarkers of inflammation, oxidative stress and quality of life in patients with type 1 diabetes
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Design
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Clinical Trial with Control Group, Parallel Groups, Double Blind, Randomized
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Settings and conduct
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Patients, who are eligible according to Inclusion and exclusion criteria, would be invited to Isfahan Endocrine and Metabolism Research Center . For randomization, random blocks with quadrilateral blocks will be used.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Signed Consent Written Consent
2. HbA1c above 7%
3. Aged 65-18 years
4. Duration of more than 1 Year
5. Treatment with Multiple Injections of Insulin.
Exclusion criteria:
1. Pregnancy
2. Other autoimmune diseases
3. Hyperglycemia leads to ketoacidosis over the past month
4. Use of mixed insulins
5. Use Supplements Related to the Study
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Intervention groups
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Individuals in the Intervention Group will Receive a 50000 IU Vitamin D supplementation every 2 Weeks and also They will Receive 1 Synbiotic capsules per day for 12 Weeks.
Individuals in the Control Group will Receive Vitamin D Pelacebo every 2 Weeks and also They will Receive 1 Synbiotic Placebo per Day for 12 Weeks.
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Main outcome variables
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The Primary Outcomes of this Study are Hemoglobin A1C, Serum 25 hydroxyvitamin D Levels and Total Insulin,Tumour Necrosis Factor α , High Sensitivity C-Reactive Protein, Total Antioxidant Capacity, Malondialdehyde .
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180127038521N1
Registration date:
2018-04-02, 1397/01/13
Registration timing:
registered_while_recruiting
Last update:
2019-09-14, 1398/06/23
Update count:
1
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Registration date
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2018-04-02, 1397/01/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-06, 1396/12/15
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The Effect of Vitamin D and Synbiotic Supplementation in Type 1 Diabetes.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
114
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-27, 1396/08/05
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Ethics committee reference number
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IR.IUMS.FMD.REC 1396.۹۵۱۱۳۲۳۰۰۱
Health conditions studied
1
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Description of health condition studied
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Type 1 Diabetes
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ICD-10 code
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E10
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ICD-10 code description
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Type 1 diabetes mellitus
Primary outcomes
1
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Description
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Hemoglobin A1c
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Timepoint
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Before and After Intervention
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Method of measurement
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Biochemical Test
2
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Description
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Serum Level of 25 Hydroxyvitamin D
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Timepoint
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Before and After Intervention
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Method of measurement
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Biochemical Test
3
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Description
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Total Insulin Demand
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire
4
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Description
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High Sensitivity C-Reactive Protein
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Timepoint
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Before and After Intervention
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Method of measurement
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Chemiluminescence
5
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Description
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Tumour Necrosis Factor α
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Timepoint
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Before and After Intervention
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Method of measurement
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ELISA
6
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Description
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Total Antioxidant Capacity
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Timepoint
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Before and After Intervention
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Method of measurement
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Colorimetric
7
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Description
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Malondialdehyde
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Timepoint
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Before and After Intervention
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Method of measurement
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Colorimetric
Secondary outcomes
1
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Description
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Fasting Blood Glucose
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Timepoint
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Before and After Intervention
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Method of measurement
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Biochemical Test
2
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Description
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Triglyceride
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Timepoint
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Before and After Intervention
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Method of measurement
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Photometric
3
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Description
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Total Cholesterol
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Timepoint
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Before and After Intervention
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Method of measurement
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Photometric
4
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Description
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HDL-Cholesterol
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Timepoint
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Before and After Intervention
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Method of measurement
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Enzymatic Method
5
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Description
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LDL-Cholesterol
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Timepoint
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Before and After Intervention
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Method of measurement
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Enzymatic Method
6
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Description
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Systolic Blood Pressure
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Timepoint
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Before and After Intervention
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Method of measurement
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Mercuric Barometer
7
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Description
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Diastolic Blood Pressure
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Timepoint
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Before and After Intervention
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Method of measurement
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Mercuric Barometer
8
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Description
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Interleukin 17
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Timepoint
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Before and After Intervention
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Method of measurement
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ELISA
9
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Description
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Insulin Resistance
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Timepoint
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Before and After Intervention
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Method of measurement
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Estimated Glucose Disposal Rate
10
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Description
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Weight
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Timepoint
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Before and After Intervention
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Method of measurement
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scale
11
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Description
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Body Mass Index
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Timepoint
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Before and After Intervention
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Method of measurement
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Calculation
12
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Description
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Waist Circumference
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Timepoint
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Before and After Intervention
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Method of measurement
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Measuring Tape
13
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Description
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Waist / Hip Ratio
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Timepoint
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Before and After Intervention
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Method of measurement
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Calculation
14
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Description
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Injected Insulin Dose
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire
15
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Description
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Number of Insulin Injections
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire
16
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Description
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Hand Grip
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Timepoint
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Before and After Intervention
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Method of measurement
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Dynamometer
17
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Description
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Quality-of-Life
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire Quality-of-Life
18
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Description
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Mood
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire Beck Depression
19
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Description
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Mean Arterial Pressure
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Timepoint
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Before and After Intervention
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Method of measurement
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Calculation
20
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Description
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Hip circumference
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Timepoint
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Before and After Intervention
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Method of measurement
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Measuring Tape
21
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Description
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Bloating condition
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Timepoint
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Before and After Intervention
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Method of measurement
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Questionnaire
22
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Description
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Body fat percentage
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Timepoint
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Before and After Intervention
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Method of measurement
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inbody scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Vice Dean of Research of Iran University of Medical Science
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available