A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)

What Was Tested

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

The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale.

The study duration is 20 weeks.

It had two arms (groups): Vegan diet and vitamin B12 supplement (experimental) and Vitamin B12 supplement (active comparator).

The diet/supplement group will be asked to follow a low-fat, vegan diet for 20 weeks, and take a vitamin B12 supplement daily.

The supplement group will be asked to take a daily vitamin B12 supplement, and to make no changes to their current diet.

The registry classes the interventions as dietary supplement and other.

More on the Plan

The following determinations will be made at baseline, mid-point, and end of each 20-week study period, as well as at one-year follow up: General status, symptoms, and medication accounting.

Participants will be asked to report changes in their health and medication use.

The following assessments will be used to measure pain and changes in sensory perception related to diabetic neuropathy: Michigan Neuropathy Screening Instrument.

The MNSI questionnaire consists of 15 questions followed by a single 8-point clinical examination involving inspection of the foot, assessment of ankle reflexes, and semi-quantitative determination of vibration perception.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Men and women age 18 - 65 years old. A diagnosis of type 2 diabetes. A diagnosis of diabetic neuropathy for at least 6 months or symptoms of diabetic neuropathy for at least 6 months. Score of greater than 2 on the Michigan Neuropathy Screening Instrument. Score of greater than 6on the Norfolk Quality of Life Questionnaire.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: vitamin b12 deficiency; use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion); unstable medical or psychiatric illness.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2013-09 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Pain (time frame: 20 weeks).

It also tracked 5 secondary outcomes, for example Sensation, Disease activity, Glycemic control, Mood and Quality of life.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 20 people.

Its size is small, so on its own it can only give an early look.

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.