NCT05561738 · University of Pittsburgh
Nicotinamide Riboside in Ulcerative Colitis
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
View original scientific description
This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
Interventions
DIETARY_SUPPLEMENT
Nicotinamide Riboside Chloride
The intervention consists of 6 months to 1 year of daily oral therapy with Nicotinamide Riboside Chloride (Niagen) in addition to standard therapy.
DIETARY_SUPPLEMENT
Placebo
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.
OTHER
Standard of Care
Standard of Care
Primary outcome measures
Number of patients screened
Time frame: 2 years
The investigators will report the number of overall patients screened for enrollment.
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.
Enrollment percentage
Time frame: 2 years
The investigators will report the proportion of eligible patients who enroll in the study per month.
Completion percentage
Time frame: 2 years
The investigators will report the proportion of enrolled subjects who complete the study.
Reasons for exclusion
Time frame: 2 years
The investigators will report the reasons that patients are excluded from the study.
Dropout rate
Time frame: 2 years
The investigators will report the percentage of subjects who drop out per month.
Reasons for dropout
Time frame: 2 years
The investigators will log reasons for dropout.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Pittsburgh, Pennsylvania
Collaborators
Crohn's and Colitis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations