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IRCT20230702058641N2 IRCT 2024-02-01 Shahre-kord University of Medical Sciences The effect of vitamin B5 on stress; depression and anxiety 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 2024-01-20 anticipated 48 Complete https://irct.ir/trial/74085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, 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 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. 3 Type 2 diabetes. Intervention 1: 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. Intervention 2: Control group: Placebo along with metformin/insulin will be given to them for 8 weeks. There have been limited research on the impact of a particular dietary pattern, like consuming pantothenic acid, on the emergence of stress, anxiety, and depression during diabetes induction. According to this issue, this study was designed. The study involved 38 patients aged 30–65 with type 2 diabetes, divided into two groups receiving vitamin B5 and a control group. The intervention group received 250 mg of vitamin B5 tablets for two months, and stress, anxiety, and depression parameters and the level of cortisol were measured at the start and end of the study. The results showed that in the intervention group, situational anxiety (P<0.01), cortisol level (P<0.05), depression score (P<0.01), and anxiety score of Dass-21 (P = 0.001) after the intervention were significantly lower than before the intervention. The difference (after-before) between trait anxiety (P<0.05), situational anxiety (P = 0.002), and anxiety score (P<0.001) in the intervention group was significantly lower than the control group. Also, the difference (after-before) in the limitation due to physical health status (P = 0.001), limitation due to emotional health status (P = 0.002), and cortisol level (P = 0.031) in the intervention group was significantly higher than the control group. Vitamin B5 supplementation may reduce depression and cortisol levels in type 2 diabetes patients but doesn't affect anxiety, highlighting the need for future studies to understand its role. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: It will be available for researchers working in academic and scientific institutions Conditions: The data can be used after obtaining permission from both supervisors Where to obtain: Reihane Sadeghian; Adress: University Headquarters; Kashani Blvd.; Shahrekord. Postal code: 8815713471. Phone number: 038-0333061-5-3333061; Email: reihaneh.sadeghian5@gmail.com How to obtain: The data can be accessed after the official letter from the Research and Technology Vice-Chancellor of the relevant university. Comments:
public Reihaneh Sadeghian
Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3334 9509 reihaneh.sadeghian5@gmail.com Shahre-kord University of Medical Sciences scientific Golshan Taghipour
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord
Shahrekord Iran (Islamic Republic of) 8816854633 +98 913 184 2580 golshan.taghipour@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 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. 30 years 65 years Both 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 E11 Type 2 diabetes mellitus Treatment - Drugs Placebo 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. Control group: Placebo along with metformin/insulin will be given to them for 8 weeks. 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. 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. 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. Cortisol level. Timepoint: At the beginning of the study and after two months. Method of measurement: ELISA technique. Nitric oxide levels. Timepoint: At the beginning of the study and after two months. Method of measurement: Gress method. Malondialdehyde level. Timepoint: At the beginning of the study and after two months. Method of measurement: Thiobarbituric acid method. Antioxidant capacity. Timepoint: At the beginning of the study and after two months. Method of measurement: FRAP measurement. Shahre-kord University of Medical Sciences Approved 2023-11-21 Shahrekord University of Medical Sciences Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)