Nicotinamide Riboside in Ulcerative Colitis

Last updated: January 16, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Standard of Care

Nicotinamide Riboside Chloride

Placebo

Clinical Study ID

NCT05561738
STUDY22060104
  • Ages < 18
  • All Genders

Study Summary

This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients (≤18yo);

  • Diagnosis of mild to moderate ulcerative colitis as determined by PediatricUlcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo) at the timeof colonoscopy;

  • Although the investigators will target newly diagnosed patients (therefore,treatment naïve), patients with established disease will also be enrolled.

Exclusion

Exclusion Criteria:

  • Patients with acute severe ulcerative colitis;

  • Concurrent gastrointestinal infection (ie. Clostridium difficile, Cytomegalovirus,etc.);

  • A diagnosis of Crohn's disease;

  • Indeterminate colitis/IBD-U;

  • In general, patients that have been treated with steroids or antibiotics in the pastthree months. Patients on Biologic medications may be enrolled if their dose hasbeen stable for at least three months. Final determination of eligibility will be atthe discretion of the treating investigator. After the initiation of the study,subjects may receive any medication to treat their disease as dictated by their careproviders;

  • Patients who have other chronic inflammatory/autoimmune disorders or priormalignancy;

  • Pregnant women (All women of childbearing age will be required to use contraceptionat the time of inclusion).

  • Patients with existing renal or hepatic dysfunction;

  • Per standard of care guidance, subjects with platelets <50,000 do not undergoendoscopy and, therefore, are not eligible.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Standard of Care
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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. The investigators hypothesize that daily NR supplementation will restore NAD+ levels, enhancing Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1α) activity and mitochondrial structure/function.

Connect with a study center

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

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