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IRCT20210925052566N3 IRCT 2024-01-31 Tehran University of Medical Sciences vitamin B12 supplementation in patients with diabetic peripheral neuropathy The effects of vitamin B12 supplementation in patients with diabetic peripheral neuropathy and low serum vitamin b12 2024-02-29 anticipated 40 Complete https://irct.ir/trial/74235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 50 patients with liver fibrosis, who have inclusion criteria and do not have exclusion criteria, based on a pre-designed random list (the list will be designed through the website https://www.sealedenvelope.com/simple-randomiser/v1/lists) ) will be randomly assigned to two groups to receive vitamin b12 (1000 mcg/d or 2000 mcg/d). Each drug package is assigned a code, the codes will be A and B. To reduce the bias in placing people in the treatment or placebo groups, patients will be randomly assigned to one of the two groups using the blocked randomization method (the size of the blocks is 2), Blinding description: In this study, blinding will be done in the type of supplements for researchers and patients. In this way, the appearance of the capsules will be the same and their packaging will be the same. Coding (codes will be A and B) will be done by someone outside the study. 3 diabetic peripheral neuropathy. Intervention 1: Intervention group: vitamin B12 500 mcg EuRovital (twice a day),The patients will be received 1 tablet of 500 mcg of vitamin B12 two times daily for 4 months. Intervention 2: Intervention group: vitamin B12 1000 mcg EuRovital (twice a day),The patients will be received 2 tablet of 500 mcg of vitamin B12 two times daily for 4 months. Yes - There is a plan to make this available What will be shared: Data collected for the primary and secondary outcomes will be shared. When: Access starting 6 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by for conducting Meta-analysis. Where to obtain: To access the required data, the researchers can contact Dr. Sayed Mahmoud Sajjadi Jazi: email address: mahmood.sajadi@gmail.com How to obtain: The request will be assessed by the our group, and if all of us agree to the request, the requested data will be emailed. Comments:
public Asieh Mansour
Shariati Hospital, Kargar Shomali Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0071 asiehmansour@yahoo.com Tehran University of Medical Sciences scientific Sayed Mamood Sajjadi -jazi
Shariati Hospital, Kargar Shomali, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mahmood.sajadi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients will eligible for recruitment with a MNSI of 2 or higher, abnormal NCS results age 30-70 years old low levels of vitamin B12 30 years 70 years Both current pregnancy or lactating women, alcohol intake, current smoker, diabetic foot mental disease, heart failure, cancer evidence of liver disease (such as viral hepatitis, autoimmune hepatitis, etc.) impaired renal (GFR < 30) (HbA1c>9%) E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Drugs Treatment - Drugs Intervention group: vitamin B12 500 mcg EuRovital (twice a day),The patients will be received 1 tablet of 500 mcg of vitamin B12 two times daily for 4 months. Intervention group: vitamin B12 1000 mcg EuRovital (twice a day),The patients will be received 2 tablet of 500 mcg of vitamin B12 two times daily for 4 months. Michigan neuropathy screening instrument (MNSI). Timepoint: Baseline and 16 weeks. Method of measurement: Using standard scoring systems and questionnaires. Scoring is: Michigan neuropathy screening instrument , (0-10). Neuropathy disability score (NDS). Timepoint: Baseline and 16 weeks. Method of measurement: Using standard scoring systems and questionnaires. Scoring is: Neuropathy disability score (0-10). Pain score. Timepoint: Baseline and 16 weeks. Method of measurement: Patients will be asked to score pain on a visual analog scale 0-10 with 10 being the worst pain ever. Fasting glucose and HBA1c. Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Lipid profiles (HDL-c, LDL-c, TG, TC). Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Tehran University of Medical Sciences Approved 2023-07-31 Research Ethics Committees of Endocrine & Metabolism Research Institute - Tehran University of Medic Shariati Hospital, Kargar Shomali Ave. Tehran Tehran Iran (Islamic Republic of)