The effect of vitamin B5 administration compared to placebo on stress; depression; Anxiety, oxidative stress level and serum cortisol level in type 2 diabetes patients
Determining the effect of vitamin B5 administration on stress; depression; anxiety, oxidative stress level and cortisol level in patients with type 2 diabetes
Design
Clinical trial with a control group, double-blind, randomized, phase 2 on 48 patients. The randomized treatment allocation sequence will be generated by the statistical consultant using a table of random numbers.
Settings and conduct
The current clinical trial study will be conducted on 48 patients with type 2 diabetes referred to the Imam Ali clinic in Shahrekord. After the diagnosis of type 2 diabetes and stress, anxiety, or depression, their cortisol level will be evaluated. Then, for two months, they will be given vitamin B5 tablets (250 mg) or a placebo in a blinded manner, and the status of the investigated parameters will be checked at the end of the two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30-65 years; not taking oral contraceptives in the last month; non-smokers; People who have not received vitamin B supplements at least 3 months before the study; People who are not professional athletes.
Exclusion criteria: non-cooperation of patients to participate in the study; the presence of congenital anxiety diseases; incomplete completion of the questionnaire; People taking combined oral blood sugar-lowering drugs such as Sinuripa tablets; People taking drugs related to severe depression (bipolar); People taking vitamin B5 supplements before starting the tests
Intervention groups
The intervention group: will receive vitamin B5 chewable tablets along with metformin/insulin.
The control group: the group of diabetic patients who will receive metformin/insulin along with placebo.
Main outcome variables
Average score of depression; Average score of anxiety; Average score of stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230702058641N2
Registration date:2024-02-01, 1402/11/12
Registration timing:registered_while_recruiting
Last update:2024-02-01, 1402/11/12
Update count:1
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Reihaneh Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 205 8035
Email address
reihaneh.sadeghian5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B5 administration compared to placebo on stress; depression; Anxiety, oxidative stress level and serum cortisol level in type 2 diabetes patients
Public title
The effect of vitamin B5 on stress; depression and anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-65 years
People who are not professional athletes.
Receiving metformin/insulin.
Patients should not take melatonin, aspirin, D3, omega3 during the study period.
Not taking oral contraceptives in the last month
people who have not received vitamin B supplements at least 3 months before the study.
Exclusion criteria:
Non-cooperation of patients to participate in the study
Use of corticosteroids and anticoagulants in the last month
Smokers
The existence of congenital cognitive and anxiety diseases
Incomplete completion of the questionnaire
People taking combined oral hypoglycemic drugs such as Sinuripa tablets
People taking drugs related to severe depression (bipolar)
People taking vitamin B5 supplements before starting the tests
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients are randomly divided into two groups "control and intervention" after examination and if they meet the criteria to enter the plan. By using online sites for random allocation, random block method with blocks of 4 will be used. For the random sequence, a numerical code will be defined and people will receive the numerical code in the same order as they enter and will be placed in groups according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (researcher and patients do not know which person is assigned to which treatment group). Patients were also blinded according to the received intervention, which is the use of tablets with the same shape, taste, and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord, Shariati Blvd., Imam Ali (A.S.) Specialized Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.SKUMS.MED.REC.1402.063
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Score of depression
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
2
Description
Score of anxiety
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
3
Description
Score of stress
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
Secondary outcomes
1
Description
Cortisol level
Timepoint
At the beginning of the study and after two months
Method of measurement
ELISA technique
2
Description
Nitric oxide levels
Timepoint
At the beginning of the study and after two months
Method of measurement
Gress method
3
Description
Malondialdehyde level
Timepoint
At the beginning of the study and after two months
Method of measurement
Thiobarbituric acid method
4
Description
Antioxidant capacity
Timepoint
At the beginning of the study and after two months
Method of measurement
FRAP measurement
Intervention groups
1
Description
Intervention group: vitamin B5 chewable tablet with a dose of 250 mg (produced by Shehab Pharmaceutical Company) once a day, which will be given to them along with metformin/insulin for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo along with metformin/insulin will be given to them for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic/Shahrekord University of Medical Sciences
Full name of responsible person
گلشن تقی پور بروجنی
Street address
Shahrekord, Shariati Blvd., Imam Ali (A.S.) Specialized Clinic
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3224 2696
Email
golshan.taghipour@gmail.com
Web page address
https://imamaliclinic.skums.ac.ir/#
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Golshan Taghipour
Street address
Shahrekord, Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 913 184 2580
Email
golshan.taghipour@gmail.com
Web page address
https://imamaliclinic.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Reihaneh Sadeghian
Position
Assistant Professor of neurophysiology
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 9509
Email
reihaneh.sadeghian5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Golshan Taghipour
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord