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NCT Number: NCT05561738

Nicotinamide Riboside in Ulcerative Colitis

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

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Kevin P Mollen, MD

PRINCIPAL_INVESTIGATOR

Min Shi

CONTACT

[email protected]

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients (≤18yo);
  • Diagnosis of mild to moderate ulcerative colitis as determined by Pediatric Ulcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo) at the time of colonoscopy;
  • Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled.

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 past three months. Patients on Biologic medications may be enrolled if their dose has been stable for at least three months. Final determination of eligibility will be at the discretion of the treating investigator. After the initiation of the study, subjects may receive any medication to treat their disease as dictated by their care providers;
  • 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).
  • Patients with existing renal or hepatic dysfunction;
  • Per standard of care guidance, subjects with platelets <50,000 do not undergo endoscopy and, therefore, are not eligible.

Treatment and study plan

Nicotinamide Riboside Chloride

Dietary Supplement

The intervention consists of 6 months to 1 year of daily oral therapy with Nicotinamide Riboside Chloride (Niagen) in addition to standard therapy.

Placebo

Dietary Supplement

The intervention consists of 6 months to 1 year of daily oral therapy with placebo (Maltodextran capsules of similar size, shape and color as Niagen) in addition to standard therapy.

Standard of care

Other

Standard of Care

Primary outcomes

  1. Number of patients screened

    Time frame: 2 years

    The investigators will report the number of overall patients screened for enrollment.

  2. Proportion of patients screened who meet inclusion/exclusion criteria

    Time frame: 2 years

    The investigators will report the number of patients screened who meet inclusion/exclusion criteria.

  3. Enrollment percentage

    Time frame: 2 years

    The investigators will report the proportion of eligible patients who enroll in the study per month.

  4. Completion percentage

    Time frame: 2 years

    The investigators will report the proportion of enrolled subjects who complete the study.

  5. Reasons for exclusion

    Time frame: 2 years

    The investigators will report the reasons that patients are excluded from the study.

  6. Dropout rate

    Time frame: 2 years

    The investigators will report the percentage of subjects who drop out per month.

  7. Reasons for dropout

    Time frame: 2 years

    The investigators will log reasons for dropout.

Secondary outcomes

  1. Changes in mitochondrial structure from baseline to 6-12 months

    Time frame: Baseline 6-12 months

    Subjects will undergo colonoscopic evaluation at enrollment and after 6-12 months of treatment (per standard treatment protocols). Investigators will perform a qualitative analysis of mitochondrial structure using scanning electron microscopy and/or immunofluorescence at both timepoints.

  2. Changes in mitochondrial function from baseline to 6-12 months

    Time frame: Baseline 6-12 months

    Subjects will undergo colonoscopic evaluation at enrollment and after 6-12 months of treatment (per standard treatment protocols). Investigators will evaluate mitochondrial function (Complex 1 and 2) via the Oroboros 2K Analyzer [oxygen consumption [(pmol/(s × mL)/μg protein] at both timepoints.

  3. Changes in the PGC1α-Sirt1 axis from baseline to 6-12 months

    Time frame: Baseline 6-12 months

    Subjects will undergo colonoscopic evaluation at enrollment and after 6-12 months of treatment (per standard treatment protocols). PGC1α and Sirt1 levels will be evaluated in tissue biopsies using western blot (qualitative analysis of protein levels) and qRT-PCR analysis (quantitative gene expression in fold change) at both timepoints.

  4. Changes in cellular metabolism from baseline to 6-12 months

    Time frame: Baseline 6-12 months

    Subjects will undergo colonoscopic evaluation at enrollment and after 6-12 months of treatment (per standard treatment protocols). An untargeted metabolomic analysis of the intestinal epithelium will be performed at these time points (fold change) at both timepoints.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Crohn's and Colitis Foundation

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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