Vitamin-Like supplement tested for diabetic nerve pain – but trial stopped early
NCT ID NCT03685253
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested whether nicotinamide riboside (a form of vitamin B3 sold as Niagen) could help repair nerve damage in people with type 2 diabetes or prediabetes. Only 10 participants were enrolled before the study was terminated. The main goal was to measure changes in nerve fiber density in the skin. Because the trial was small and stopped early, it's unclear if this supplement offers any benefit for diabetic neuropathy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nicotinamide riboside (Niagen)
- What this could lead to
- If it works, this could point toward a treatment for diabetic nerve damage by helping restore nerve fibers.
- What could go wrong
- This was a very small, early-phase trial that was terminated, so we don't have clear evidence it works. The supplement may not improve nerve health in people with diabetes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
10 people
The number who actually took part.
- Started
-
Jan 2019
- Finished
-
May 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Impaired glucose tolerance or controlled type 2 diabetes mellitus at the time of screening or within three months of screening\*. 2. The hemoglobin A1c may be normal, but should be less than 9%. 3. If diabetic participants are on medication, they should be stable on medication for at least 3 months prior to entering the study. Addition or change in antidiabetic medication (if on medication) after enrollment does not affect participation or group assignment. 4. Impaired glucose regulation is the most likely cause of the neuropathy. 5. Mild diabetic polyneuropathy as defined by the Toronto Diabetic Neuropathy Expert Group consensus criteria. 6. Age 30 (to exclude patients with type 1 diabetes) to 80 years inclusive. 7. Medically stable at the time of enrollment. 8. Willing to accept randomization assignment and compliance with the study procedures. Exclusion Criteria: 1. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study. 2. Patient must agree to take an alternative medication to Warfarin or Factor X inhibitors when undergoing a skin biopsy. 3. Neuropathy due to factors other than type 2 diabetes mellitus based on careful clinical and laboratory evaluation by the study physicians. 4. Abnormal liver function tests, including alanine transaminase, aspartate transaminase, alkaline phosphatase, and bilirubin. 5. Current severe medical conditions that are active on the day of screening.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic neuropathy peripheral are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Maryland
Baltimore, Maryland, 21201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.