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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210925052566N3
Enrollment
40
Registered
2024-01-31
Start date
2024-02-29
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic peripheral neuropathy. Type 2 diabetes mellitus with neurological complications

Interventions

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: Intervent

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

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

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 9%)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Mansour

Tehran University of Medical Sciences

asiehmansour@yahoo.com+98 21 8822 0071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026