Nicotinamide Riboside in Ulcerative Colitis

NCT05561738 | Recruiting

• 1 other identifier: STUDY22060104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

NAD

Outcome Measures

Primary Outcomes (7)

• Number of patients screened

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

  2 years

• Proportion of patients screened who meet inclusion/exclusion criteria

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

  2 years

• Enrollment percentage

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

  2 years

• Completion percentage

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

  2 years

• Reasons for exclusion

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

  2 years

• Dropout rate

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

  2 years

• Reasons for dropout

  The investigators will log reasons for dropout.

  2 years

Secondary Outcomes (4)

• Changes in mitochondrial structure from baseline to 6-12 months

  Baseline 6-12 months

• Changes in mitochondrial function from baseline to 6-12 months

  Baseline 6-12 months

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

  Baseline 6-12 months

• Changes in cellular metabolism from baseline to 6-12 months

  Baseline 6-12 months

Study Arms (2)

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

EXPERIMENTAL

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).

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

Daily oral therapy with placebo + Standard Therapy

EXPERIMENTAL

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).

Dietary Supplement: Placebo; Other: Standard of Care

Interventions

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.

Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + 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.

Daily oral therapy with placebo + Standard Therapy

Standard of Care OTHER

Standard of Care

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Related Publications (9)

• Novak EA, Mollen KP. Mitochondrial dysfunction in inflammatory bowel disease. Front Cell Dev Biol. 2015 Oct 1;3:62. doi: 10.3389/fcell.2015.00062. eCollection 2015.

  PMID: 26484345 BACKGROUND

• Cunningham KE, Vincent G, Sodhi CP, Novak EA, Ranganathan S, Egan CE, Stolz DB, Rogers MB, Firek B, Morowitz MJ, Gittes GK, Zuckerbraun BS, Hackam DJ, Mollen KP. Peroxisome Proliferator-activated Receptor-gamma Coactivator 1-alpha (PGC1alpha) Protects against Experimental Murine Colitis. J Biol Chem. 2016 May 6;291(19):10184-200. doi: 10.1074/jbc.M115.688812. Epub 2016 Mar 11.

  PMID: 26969166 BACKGROUND

• Haberman Y, Karns R, Dexheimer PJ, Schirmer M, Somekh J, Jurickova I, Braun T, Novak E, Bauman L, Collins MH, Mo A, Rosen MJ, Bonkowski E, Gotman N, Marquis A, Nistel M, Rufo PA, Baker SS, Sauer CG, Markowitz J, Pfefferkorn MD, Rosh JR, Boyle BM, Mack DR, Baldassano RN, Shah S, Leleiko NS, Heyman MB, Grifiths AM, Patel AS, Noe JD, Aronow BJ, Kugathasan S, Walters TD, Gibson G, Thomas SD, Mollen K, Shen-Orr S, Huttenhower C, Xavier RJ, Hyams JS, Denson LA. Ulcerative colitis mucosal transcriptomes reveal mitochondriopathy and personalized mechanisms underlying disease severity and treatment response. Nat Commun. 2019 Jan 3;10(1):38. doi: 10.1038/s41467-018-07841-3.

  PMID: 30604764 BACKGROUND

• Larmonier CB, Shehab KW, Laubitz D, Jamwal DR, Ghishan FK, Kiela PR. Transcriptional Reprogramming and Resistance to Colonic Mucosal Injury in Poly(ADP-ribose) Polymerase 1 (PARP1)-deficient Mice. J Biol Chem. 2016 Apr 22;291(17):8918-30. doi: 10.1074/jbc.M116.714386. Epub 2016 Feb 24.

  PMID: 26912654 BACKGROUND

• Santos L, Escande C, Denicola A. Potential Modulation of Sirtuins by Oxidative Stress. Oxid Med Cell Longev. 2016;2016:9831825. doi: 10.1155/2016/9831825. Epub 2015 Dec 14.

  PMID: 26788256 BACKGROUND

• Gerner RR, Klepsch V, Macheiner S, Arnhard K, Adolph TE, Grander C, Wieser V, Pfister A, Moser P, Hermann-Kleiter N, Baier G, Oberacher H, Tilg H, Moschen AR. NAD metabolism fuels human and mouse intestinal inflammation. Gut. 2018 Oct;67(10):1813-1823. doi: 10.1136/gutjnl-2017-314241. Epub 2017 Sep 6.

  PMID: 28877980 BACKGROUND

• Mehmel M, Jovanovic N, Spitz U. Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. Nutrients. 2020 May 31;12(6):1616. doi: 10.3390/nu12061616.

  PMID: 32486488 BACKGROUND

• Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.

  PMID: 27721479 BACKGROUND

• Jiang Y , Liu Y , Gao M , Xue M , Wang Z , Liang H . Nicotinamide riboside alleviates alcohol-induced depression-like behaviours in C57BL/6J mice by altering the intestinal microbiota associated with microglial activation and BDNF expression. Food Funct. 2020 Jan 29;11(1):378-391. doi: 10.1039/c9fo01780a.

  PMID: 31820774 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kevin Mollen

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Shi

CONTACT

412-692-6272; shim@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 30, 2022
• Study Start: February 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication of the results of the study. Date will be available for 1 year.
• Access Criteria: Prior to any sharing of any data, the research data/documents will be coded and all subject identifiers will be completely removed. Only the PI and co-investigators will have access to the coding. All others will have access to the completely deidentified data only. A data use agreement will be obtained and finalized prior to any of the data leaving the institution, and prior to any access by outside entities.

Locations

US (1)