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The Effects of Vitamin D and Selenium Supplementation, Alone and in Combination, on Glycemic Indices, Inflammatory Markers, Adipokines, and Metabolic Parameters in Patients with Type 2 Diabetes

Protocol summary

Study aim
The Effects of Vitamin D and Selenium Supplementation, Alone and in Combination, on Glycemic Indices, Inflammatory Markers, Adipokines, and Metabolic Parameters in Patients with Type 2 Diabetes
Design
Clinical Trial with Control Group, Parallel Groups, Double Blind, Randomized
Settings and conduct
Patients, who are eligible according to Inclusion and exclusion criteria, would be invited to Kermanshah Endocrine and Metabolism Research Center . For randomization, random blocks with quadrilateral blocks will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include willingness to cooperate and sign a written informed consent, an HbA1c above 7% (considered uncontrolled diabetes according to the American Diabetes Association guidelines), and a duration of diabetes longer than 1 year, while exclusion criteria consist of pregnancy, autoimmune disorders (such as celiac disease, Hashimoto's, asthma, and allergies), severe hypoglycemia requiring assistance (occurring 3 or more times in the past year or 1 or more times in the past 3 months), hyperglycemia leading to ketoacidosis in the past month
Intervention groups
Participants in the intervention group will receive a vitamin D supplement of 50,000 IU every 2 weeks, and they will also receive 1 capsule of selenium (200 mcg) daily for 12 weeks. Participants in the control group will receive a placebo for vitamin D every 2 weeks, and they will also receive 1 placebo capsule of selenium daily for 12 weeks.
Main outcome variables
The Primary Outcomes of this Study are Hemoglobin A1C, Serum 25 hydroxyvitamin D Levels and Total Insulin, High Sensitivity C-Reactive Protein.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180712040438N9
Registration date: 2024-12-15, 1403/09/25
Registration timing: prospective

Last update: 2024-12-15, 1403/09/25
Update count: 0
Registration date
2024-12-15, 1403/09/25
Registrant information
Name
Jalal Moludi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2148
Email address
jmoludi@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-19, 1403/10/30
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Vitamin D and Selenium Supplementation, Alone and in Combination, on Glycemic Indices, Inflammatory Markers, Adipokines, and Metabolic Parameters in Patients with Type 2 Diabetes
Public title
Vitamin D and Selenium in Type 2 Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Signed informed consent 2. HbA1c above 7% 3. Age between 18 and 75 years 4. Duration of diabetes longer than 1 year 5. Serum vitamin D levels below 30 ng/mL 6. Patients with controlled blood sugar (HbA1c not exceeding 11%) 7. Body Mass Index (BMI) between 25 and 35 kg/m².
Exclusion criteria:
1. Pregnancy 2. Other autoimmune diseases 3. Hyperglycemia leads to ketoacidosis over the past month 4. Use of insulins 5. Use Supplements Related to the Study
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients, who are eligible according to Inclusion and exclusion criteria, would be invited to Kermanshah Endocrine and Metabolism Research Center . For randomization, random blocks with quadrilateral blocks will be used. For Randomization, the Permuted Block Randomization Method will be Used Blocks with the Size of Four . According to the Sample Size 80, 20 Blocks will be Produced Using the Online Site (www.sealedenvelope .com).
Blinding (investigator's opinion)
Triple 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 Kermanshah University of Medical Sciences
Street address
Faculty of Nutrition and Food Technology, Next to Farabi Hospital, Kermanshah, Iran , Postcode: 6719851552
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Approval date
2024-12-03, 1403/09/13
Ethics committee reference number
IR.KUMS.REC.1403.471

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Hemoglobin A1c
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

2

Description
FBS
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

3

Description
Insulin level
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

4

Description
Lipid profiles (TG, TC, LDL-c, HDL-c)
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

5

Description
PAI-1
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

6

Description
tPA
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

7

Description
hs-CRP
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

8

Description
MDA
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

9

Description
Leptin
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

10

Description
Adiponectin
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

11

Description
Visfastin
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

Secondary outcomes

1

Description
Fasting Blood Glucose
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

2

Description
Total cholesterol
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

3

Description
TG
Timepoint
Before and After Intervention
Method of measurement
Biochemical Test

Intervention groups

1

Description
Intervention group: Control group: Intervention group: The Duration of the Intervention will be 3 Months. the Intervention Group will be given one Vitamin D 50,000 IU (anufactured by Zahravi Company)every 2 weeks and One Capsule of Selenium Per Day. During the 3 Months of Intervention.
Category
Treatment - Other

2

Description
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 dextrin. They will also Receive 1 Selenium Placebo per day for 12 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Medical Research & Training Hospital
Full name of responsible person
Dr. Jalal Moludi
Street address
Imam Reza Medical Research & Training Hospital
City
Kermanshah
Province
Kermanshah
Postal code
5125814711
Phone
+98 21 8670 5503
Email
jmoludi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Krmanshah University of Medical Sciences
Street address
Vice Chancellor for Research No 2 Central Building, Kermanshah University of Medical Sciences, Beheshti Street, Tabriz
City
Krmanshah
Province
Kermanshah
Postal code
2589631478
Phone
+98 83 8380 2009
Email
jmoludi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Krmanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isar St
City
Kermanshah
Province
Kermanshah
Postal code
258625698
Phone
+98 41 3335 2148
Fax
+98 41 3335 2148
Email
moludij@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isar St
City
Kermanshah
Province
Kermanshah
Postal code
2585654232
Phone
+98 41 3335 2148
Fax
+98 41 3335 2148
Email
moludij@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isar St
City
Kermanshah
Province
Kermanshah
Postal code
2589654789
Phone
+98 41 3335 2148
Fax
+98 41 3335 2148
Email
moludij@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Proposals, dissertations and possible articles are available
When the data will become available and for how long
2024-2025
To whom data/document is available
all related researchers
Under which criteria data/document could be used
The documentary can be used as long as the intellectual rights of the authors are respected
From where data/document is obtainable
Jalal Moludi
What processes are involved for a request to access data/document
via email
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