Vitamin B12 Supplementation in Diabetic Neuropathy

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Diabetic Foot; Diabetes Mellitus; Diabetic Neuropathies; Diabetic Complication

Treatments: Other: Placebo; Dietary Supplement: B12 fix 1000mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT04706377

No42439

Details and patient eligibility

About

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 and neuropathy.

Full 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 randomized to an active treatment group (n=44) receiving B12, and a control group (n=46) receiving placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurement of sural nerve conduction velocity and amplitude, vibration perception threshold, and performed cardiovascular autonomic reflex tests (CARTs: Mean Circular Resultant, Valsalva test, postural index and orthostatic hypotension]). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet. The Michigan Neuropathy Screening Instrument Questionnaire and Examination and questionnaires to evaluate quality of life and level of pain were also used.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Active treatment group

Active Comparator group

Description:

Patients were given oral dispersible tablet with 1000μg of vitamin B12 daily for 12 months.

Treatment:

Dietary Supplement: B12 fix 1000mcg

Placebo group

Placebo Comparator group

Description:

Patients were given placebo tablet similar to the tablet given to the active group once a day for 12 months.

Treatment:

Other: Placebo