vitamin B12 supplementation in patients with diabetic peripheral neuropathy

Phase 3

Recruiting

• Conditions: diabetic peripheral neuropathy.; Type 2 diabetes mellitus with neurological complications; E11.4

• Registration Number: IRCT20210925052566N3
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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%)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.