Nicotinamide Riboside in Ulcerative Colitis

University of Pittsburgh

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Nicotinamide Riboside Chloride; Other: Standard of Care; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05561738

STUDY22060104

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy

Experimental group

Description:

Nicotinamide Riboside Chloride (Niagen) 75mg or 250mg capsules provided by ChromaDex, Inc. Dosing is recommended at 12.5mg/kg/day. The dosing plan is as follows (in mg po qD): 20-25 kg 250mg; 25-30 kg 325mg; 30-35 kg 400mg; 35-40 kg 475mg; 40-45 kg 500mg; 45-50 kg 575mg; 50-55 kg 650mg; 55-60 kg 725mg; 60-65 kg 750mg; 65-70 kg 825mg; \>70 kg 900mg (max dosing).

Treatment:

Other: Standard of Care

Dietary Supplement: Nicotinamide Riboside Chloride

Daily oral therapy with placebo + Standard Therapy

Experimental group

Description:

Placebo 75mg or 250mg capsules provided by ChromaDex, Inc. Dosing is recommended at 12.5mg/kg/day. The dosing plan is as follows (in mg po qD): 20-25 kg 250mg; 25-30 kg 325mg; 30-35 kg 400mg; 35-40 kg 475mg; 40-45 kg 500mg; 45-50 kg 575mg; 50-55 kg 650mg; 55-60 kg 725mg; 60-65 kg 750mg; 65-70 kg 825mg; \>70 kg 900mg (max dosing).

Treatment:

Dietary Supplement: Placebo

Other: Standard of Care