The Effect of Vitamin D and Synbiotic Supplementation on HbA1c, Metabolic Profile and Serum Concentration of Inflammatory Indices in Patients with Type 1 Diabetes.
The Effect of Vitamin D and Synbiotic Supplementation on Hba1c, Metabolic Profile and Serum Concentration of Inflammatory Indices in Patients with Type 1 Diabetes
Design
Clinical Trial with Control Group, Parallel Groups, Double Blind, Randomized
Settings and conduct
Patients, who are eligible According to Entrance and Egress criteria, would Refer to Imam Hospital clinics and outpatient clinics and a Diabetes Association Approved by university professors will be invited to participate in the study. This study will be conducted at the Anthropology Laboratory of the Faculty of Health of the Iran University of Medical Sciences .. For randomization, random blocks will be used with quadrilateral blocks.
Participants/Inclusion and exclusion criteria
Entrance 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
6. Do not Use Supplements Related to the Study
Egress Criteria:
1. Pregnancy
2. Other autoimmune diseases
3. Severe hypoglycemia
4. Hyperglycemia leads to ketoacidosis over the past month
5. Use of mixed insulins
6. Severe complications of diabetes
Intervention groups
Individuals in the Intervention Group will Receive a 50000 IU Vitamin D Weekly for 8 Week and One at the End of 12th Week. They will also Receive 1 Synbiotic per day for 12 Weeks.
Individuals in the Control Group will Receive 8 Vitamin D Pelacebo Weekly and One at the End of 12th Week. They will also Receive 1 Synbiotic Placebo per Day for 12 Weeks.
Main outcome variables
The Primary Outcomes of this Study are Hemoglobin A1C, Serum 25 hydroxyvitamin D Levels and Total Insulin Demand.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180127038521N1
Registration date:2018-04-02, 1397/01/13
Registration timing:registered_while_recruiting
Last update:2018-04-02, 1397/01/13
Update count:1
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Fatemehsadat Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4852
Email address
amiri.fs@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D and Synbiotic Supplementation on HbA1c, Metabolic Profile and Serum Concentration of Inflammatory Indices in Patients with Type 1 Diabetes.
Public title
The Effect of Vitamin D and Synbiotic Supplementation in Type 1 Diabetes.
Purpose
Treatment
Inclusion/Exclusion 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)
Not Taking Vitamin D Supplements(Oral and Injection), Calcium-Vitamin D, Multivitamin-Minerals, Omega-3, and Lack of Vitamin D-Enriched Foods over the Past 3 Months)
Exclusion criteria:
Pregnancy
Celiac or other Autoimmune Diseases
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)
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 and CVA
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway, Next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.IUMS.FMD.REC 1396.۹۵۱۱۳۲۳۰۰۱
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test
2
Description
Serum Level of 25 Hydroxyvitamin D
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test
3
Description
Total Insulin Demand
Timepoint
Before and After Intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test
2
Description
Triglyceride
Timepoint
Before and After Intervention
Method of measurement
Photometric
3
Description
Total Cholesterol
Timepoint
Before and After Intervention
Method of measurement
Photometric
4
Description
HDL-Cholesterol
Timepoint
Before and After Intervention
Method of measurement
Enzymatic Method
5
Description
LDL-Cholesterol
Timepoint
Before and After Intervention
Method of measurement
Enzymatic Method
6
Description
Systolic Blood Pressure
Timepoint
Before and After Intervention
Method of measurement
Mercuric Barometer
7
Description
Diastolic Blood Pressure
Timepoint
Before and After Intervention
Method of measurement
Mercuric Barometer
8
Description
Interleukin 17
Timepoint
Before and After Intervention
Method of measurement
ELISA
9
Description
Insulin Resistance
Timepoint
Before and After Intervention
Method of measurement
Estimated Glucose Disposal Rate
10
Description
Weight
Timepoint
Before and After Intervention
Method of measurement
Balance
11
Description
Body Mass Index
Timepoint
Before and After Intervention
Method of measurement
Calculation
12
Description
Waist Circumference
Timepoint
Before and After Intervention
Method of measurement
Measuring Tape
13
Description
Waist / Hip Ratio
Timepoint
Before and After Intervention
Method of measurement
Calculation
14
Description
Physical Activity
Timepoint
Before and After Intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ)
15
Description
Injected Insulin Dose
Timepoint
Before and After Intervention
Method of measurement
Questionnaire
16
Description
Number of Insulin Injections
Timepoint
Before and After Intervention
Method of measurement
Questionnaire
17
Description
Hand Grip
Timepoint
Before and After Intervention
Method of measurement
Dynamometer
Intervention groups
1
Description
Intervention group: The Duration of the Intervention will be 3 Months. According to the Guideline of the Endocrine Society, the Vitamin D and Synbiotics Group has a Single Dose of Vitamin D 50,000 IU (Manufactured by Zahravi Company) weekly for 8 Weeks, Followed by One Vitamin D 50,000 IU at the end of the 12th day, as well as 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)) will be Received During the 3 Months of Intervention. In order to Maintain Cooling Chain, each Patient is Provided with an Ice Bag for Carrying Synbiotic Supplementation.
Category
Treatment - Other
2
Description
Control group: The Intervention Duration will be 3 Months. Individuals in the Control Group will Receive 8 Vitamin D Pelacebo (Manufactured by Zahravi Company) Weekly and One at the End of 12th Week. 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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Diabetes Association
Full name of responsible person
Ali Ebrahimkhani
Street address
No. 27, Ramin Malakoti Ave, Patrice Lumumba St, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۳۹۱۴۶۶۱
Phone
+98 21 8824 8124
Email
amiri.fs@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh-Sadat Amiri
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
amiri.fs@iums.ac.ir
Grant name
Vice Dean of Research of Iran University of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh-Sadat Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
amiri.fs@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh-Sadat Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
amiri.fs@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Ebrahimkhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
mehrdade033@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available