Vitamin B12 Supplementation in Diabetic Neuropathy

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): Active treatment group (active comparator) and Placebo group (placebo comparator).

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

The registry classes the interventions as dietary supplement and other.

More on the Plan

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.

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.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (\>18 years old) with Diabetes Mellitus 2. Metformin treatment for at least 4 years.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: pernicious anemia,; gastric bypass surgery; pancreatic insufficiency.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-02-01 with completion listed for 2020-02-28.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Sural Nerve Function measured by conduction velocity (time frame: 12 months). Change in Sural Nerve Function measured by amplitude (time frame: 12 months). Change in Michigan Neuropathy Screening Instrument Questionnaire (time frame: 12 months).

It also tracked 1 secondary outcome, for example Adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.