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Dietary Supplement
Nicotinamide Riboside for Ulcerative Colitis
N/A
Recruiting
Led By Kevin Mollen
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Summary
This trial is testing if a supplement called NR can help treat UC in children. It's a small study, and NR hasn't been tested in this way before.
Who is the study for?
This trial is for children and teenagers (≤18 years old) with mild to moderate ulcerative colitis. It's open to those newly diagnosed or with established disease, but not if they have severe UC, other gastrointestinal infections, Crohn's disease, certain other inflammatory conditions, recent steroid/antibiotic use, or kidney/liver problems.
What is being tested?
The study tests Nicotinamide Riboside Chloride in young patients with Ulcerative Colitis against a placebo while maintaining standard care. Participants are randomly assigned to either the test drug or placebo without knowing which one they receive.
What are the potential side effects?
While specific side effects of Nicotinamide Riboside in this age group aren't detailed here, common ones may include nausea, fatigue, headaches and digestive discomfort. The actual side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion percentage
Dropout rate
Enrollment percentage
+4 moreSecondary study objectives
Cell Therapy
Body Weight Changes
Mitochondrial Inheritance
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Daily oral therapy with placebo + Standard TherapyExperimental Treatment2 Interventions
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).
Group II: Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard TherapyExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,462 Total Patients Enrolled
15 Trials studying Colitis
1,994 Patients Enrolled for Colitis
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,583 Total Patients Enrolled
3 Trials studying Colitis
389 Patients Enrolled for Colitis
Kevin MollenPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney or liver problems.My condition is diagnosed as indeterminate colitis or IBD-U.I am not pregnant and will use contraception if of childbearing age.I have severe ulcerative colitis.I do not have an ongoing infection in my digestive system.I have taken steroids or antibiotics in the last 3 months.I have been diagnosed with Crohn's disease.My platelet count is above 50,000.I am 18 years old or younger.I have been diagnosed with mild to moderate ulcerative colitis.I have a chronic inflammatory or autoimmune disorder, or a history of another cancer.My biologic medication dose has been stable for 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Daily oral therapy with placebo + Standard Therapy
- Group 2: Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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