Nicotinamide Riboside in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Proportion of patients screened who meet inclusion/exclusion criteria
研究概览
简要总结
This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
详细描述
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:
- To establish the feasibility of an Randomized Clinical Trial (RCT) investigating the effects of NR in pediatric patients with UC.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy
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).
干预措施: Standard of Care (Other)
Daily oral therapy with placebo + Standard Therapy
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).
干预措施: Placebo (Dietary Supplement)
Daily oral therapy with placebo + Standard Therapy
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).
干预措施: Standard of Care (Other)
Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy
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).
干预措施: Nicotinamide Riboside Chloride (Dietary Supplement)
结局指标
主要结局
Proportion of patients screened who meet inclusion/exclusion criteria
时间窗: 2 years
The investigators will report the number of patients screened who meet inclusion/exclusion criteria.
Number of patients screened
时间窗: 2 years
The investigators will report the number of overall patients screened for enrollment.
Completion percentage
时间窗: 2 years
The investigators will report the proportion of enrolled subjects who complete the study.
Reasons for exclusion
时间窗: 2 years
The investigators will report the reasons that patients are excluded from the study.
Enrollment percentage
时间窗: 2 years
The investigators will report the proportion of eligible patients who enroll in the study per month.
Dropout rate
时间窗: 2 years
The investigators will report the percentage of subjects who drop out per month.
Reasons for dropout
时间窗: 2 years
The investigators will log reasons for dropout.
次要结局
- Changes in cellular metabolism from baseline to 6-12 months(Baseline 6-12 months)
- 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)
研究者
Kevin Mollen
Associate Professor
University of Pittsburgh