UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Location status: Recruiting
NCT Number: NCT05561738
This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention consists of 6 months to 1 year of daily oral therapy with Nicotinamide Riboside Chloride (Niagen) in addition to standard therapy.
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
Time frame: 2 years
The investigators will report the number of overall patients screened for enrollment.
Time frame: 2 years
The investigators will report the number of patients screened who meet inclusion/exclusion criteria.
Time frame: 2 years
The investigators will report the proportion of eligible patients who enroll in the study per month.
Time frame: 2 years
The investigators will report the proportion of enrolled subjects who complete the study.
Time frame: 2 years
The investigators will report the reasons that patients are excluded from the study.
Time frame: 2 years
The investigators will report the percentage of subjects who drop out per month.
Time frame: 2 years
The investigators will log reasons for dropout.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Pittsburgh
Other
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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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