Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration

What Was Tested

The trial (phase 2) is built around NAD+.

Furthermore, the effects on nerve regeneration will also be evaluated.

The results will be compared to a placebo control drug.

It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).

Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug.

The registry classes the interventions as drug.

More on the Plan

Small fiber neuropathy (SFN) is a type of peripheral neuropathy that affects the small unmyelinated fibers, including both somatic innervation of the skin and autonomic nerves.

This experimental human model has been used previously to evaluate the rate of nerve degeneration and regeneration in several peripheral neuropathies and in healthy subjects.

Who Took Part

45 actual participants took part.

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

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

Examples of who could join: Normal neurological examination defined as Neuropathy Impairment Score \<2.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: history of peripheral neuropathy; any peripheral neuropathy risk factor including diabetes, vitamin b12 deficiency, hiv-infection, chronic kidney or hepatic disease, hypothyroidism, chemotherapy or other know neurotoxic exposure.

How the Study Was Run

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

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-09-01 with completion listed for 2023-05-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Denervation of Skin (time frame: 2 days). Reinnervation of Skin (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 45 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the NAD+ compound page, all human trials.