Nicotinamide Riboside in Ulcerative Colitis

What Was Tested

In this not phased trial, researchers set out to test NAD+.

It had two arms (groups): Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy (experimental) and Daily oral therapy with placebo + Standard Therapy (experimental).

The registry classes the interventions as dietary supplement and other.

More on the Plan

The investigators hypothesize that NR will alleviate mitochondrial dysfunction and restore metabolic homeostasis in the intestinal epithelium in pediatric patients with UC.

The purpose of the study are: 1.

To establish the feasibility of an Randomized Clinical Trial (RCT) investigating the effects of NR in pediatric patients with UC. 2.

To evaluate the effects of Nicotinamide adenine dinucleotide (NAD)+ repletion on intestinal epithelial mitochondrial structure and function in human UC patients.

Who Took Part

19 actual participants took part.

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

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

Examples of who could join: Pediatric patients (≤18yo);. Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: concurrent gastrointestinal infection (ie. clostridium difficile, cytomegalovirus, etc.);; patients who have other chronic inflammatory/autoimmune disorders or prior malignancy;; pregnant women (all women of childbearing age will be required to use contraception at the time of inclusion).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

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, care provider, investigator and outcomes assessor.

It started in 2024-02-28 with completion listed for 2026-06-30.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of patients screened (time frame: 2 years). Proportion of patients screened who meet inclusion/exclusion criteria (time frame: 2 years). Enrollment percentage (time frame: 2 years).

It also tracked 4 secondary outcomes, for example Changes in mitochondrial structure from baseline to 6-12 months, Changes in mitochondrial function from baseline to 6-12 months, Changes in the PGC1α-Sirt1 axis from baseline to 6-12 months and Changes in cellular metabolism from baseline to 6-12 months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 19 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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