Vitamin B12 Supplementation in Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetic Neuropathies Diabetic Complication Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Placebo Controlled Randomized Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The tablets containing B12 and placebo had a similar appearance and were packed in similar containers. Patients and health care providers did not know what each package contained.

Study Groups

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Active treatment group

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

Group Type ACTIVE_COMPARATOR

B12 fix 1000mcg

Intervention Type DIETARY_SUPPLEMENT

oral dispersible tablet with vitamin B12 1000mcg

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet

Interventions

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B12 fix 1000mcg

oral dispersible tablet with vitamin B12 1000mcg

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablet

Intervention Type OTHER

Other Intervention Names

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vitamin B12

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No