Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

What Was Tested

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

Metanx is a medical food available with a prescription from a physician.

It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively.

It had 1 arm (groups): Metanx (experimental).

Metanx bid for 2 weeks then daily. Compare to non treated patient population.

The registry classes the interventions as other.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Consecutive diabetic patients entering the office (private practice). Subjective symptoms of numbness, burning, paresthesia, etc. Failed Monofilament of at least two points on each foot. Abnormal PSSD study. Willing to participate in protocols or study.

The full record lists 10 inclusion and 3 exclusion criteria; among the exclusions: history of back problems (surgery or ecsi) or other large fiber neuropathies; history of chemotherapy; history of chemical exposure.

How the Study Was Run

Design: randomized, single-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.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-06 with completion listed for 2008-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Epidermal Nerve Density Count (time frame: 2 years).

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.