Status:
COMPLETED
Vitamin B12 Supplementation in Diabetic Neuropathy
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
University of Sheffield
University Hospital Tuebingen
Conditions:
Diabetes Mellitus
Diabetic Neuropathies
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes mellitus type 2 an...
Detailed Description
In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin treatment for at least four years, and both peripheral and autonomic diabetic neuropathy were...
Eligibility Criteria
Inclusion
- adults (\>18 years old) with Diabetes Mellitus 2
- established Diabetic neuropathy, both peripheral and autonomic (Diabetic Peripheral Neuropathy and Diabetic Autonomic Neuropathy). (Diagnosis was made with a)two or more Cardiovascular Autonomic Reflex Tests abnormal, b)abnormal nerve conduction velocity, c)abnormal Michigan Neuropathy Screening Instrument Questionnaire and Michigan Neuropathy Screening Instrument Examination ).
- good glycemic control (HbA1c between 6.5 and 7.5 %), stable in the last year before participating in the study
- metformin treatment for at least 4 years
- low vitamin B12 levels according to suggested normal values for DM2 patients over 60 years old (\<400 pmol/L)
Exclusion
- pernicious anemia,
- alcoholism
- gastrectomy
- gastric bypass surgery
- pancreatic insufficiency
- malabsorption syndromes
- chronic giardiasis
- acute infection in the last 6 months
- cardiovascular event in the last 6 months
- surgery involving small intestine or Human Immunodeficiency Virus infection.
- Patients with estimated Glomerular Filtration Rate \<50 mL/min/1.73m2
- taking multivitamins or B12 supplements in the last 12 months
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04706377
Start Date
February 1 2018
End Date
February 28 2020
Last Update
January 12 2021
Active Locations (1)
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1
University General Hospital AHEPA
Thessaloniki, Thessaloniki, Greece, 54621