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

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.

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.

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

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.

Average score of depression; Average score of anxiety; Average score of stress

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.

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.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

It will be available for researchers working in academic and scientific institutions

The data can be used after obtaining permission from both supervisors

Reihane Sadeghian; Adress: University Headquarters; Kashani Blvd.; Shahrekord. Postal code: 8815713471. Phone number: 038-0333061-5-3333061; Email: reihaneh.sadeghian5@gmail.com

The data can be accessed after the official letter from the Research and Technology Vice-Chancellor of the relevant university.

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.