Pilot Randomized Crossover Trial of Nicotinamide Riboside in Chronic Kidney Disease (NR-CKD Trial)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism.
The main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function.
Participants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period.
Study visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.
详细描述
Chronic kidney disease is associated with impaired mitochondrial function, vascular dysfunction, reduced physical function, and increased risk of cardiovascular and functional decline. Nicotinamide riboside is a vitamin B3 derivative and NAD+ precursor that may support cellular energy metabolism and vascular health.
This pilot study will evaluate the feasibility of using nicotinamide riboside in adults with moderate chronic kidney disease. The study uses a randomized, double-blind, placebo-controlled crossover design so that each participant receives both nicotinamide riboside chloride and placebo during separate treatment periods.
In addition to feasibility measures, the study will collect exploratory data on mitochondrial, microvascular, and physical function outcomes. These data will help determine whether a larger clinical trial of nicotinamide riboside in chronic kidney disease is practical and scientifically justified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL/min/1.73 m2 using the CKD-EPI equation.
- •Urine albumin-to-creatinine ratio (uACR) <300 mg/g.
- •Able to provide informed consent.
- •Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.
- •Willing and able to comply with study procedures, visits, and study product administration.
排除标准
- •Pregnancy.
- •Expectation to start dialysis within 6 months.
- •Unable to walk unassisted from room to room.
- •Institutionalization or inability to consent.
- •End-stage liver disease with cirrhosis.
- •Oxygen-dependent COPD.
- •Baseline systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg.
- •Current participation in another interventional trial.
- •Use of immunosuppressive medications, including steroids or calcineurin inhibitors.
- •Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.
- •Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.
研究组 & 干预措施
Placebo Then NR
Participants assigned to this arm will receive matched placebo for 12 weeks, followed by an approximately 14-day washout/crossover period, then nicotinamide riboside 1000 mg/day for 12 weeks.
干预措施: Matched Placebo (Capsules) (Dietary Supplement)
NR Then Placebo
Participants assigned to this arm will receive nicotinamide riboside 1000 mg/day for 12 weeks, followed by an approximately 14-day washout/crossover period, then matched placebo for 12 weeks.
干预措施: Nicotinamide Riboside (NR) (Dietary Supplement)
结局指标
主要结局
Recruitment Rate
时间窗: From study opening to completion of enrollment, up to 18 months
Percentage of eligible approached participants who consent and are randomized.
Retention Rate
时间窗: Through the end of the study period; Week 26
Percentage of randomized participants who complete both treatment periods and the Week 26 final study visit.
Study Product Adherence
时间窗: Weeks 12 and 26
Adherence will be assessed using study product dispensing and return records, pill count or participant-reported remaining product, and monthly adherence calls. Adherence success is defined as taking at least 75% of prescribed doses during a treatment period.
Change in plasma cell-free mitochondrial DNA
时间窗: Baseline, Week 12, and Week 26
Change in plasma cell-free mitochondrial DNA concentration, measured as mitochondrial DNA copies per mL of plasma using droplet digital PCR.
Change in urine cell-free mitochondrial DNA
时间窗: Baseline, Week 12, and Week 26
Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity.
次要结局
- Change in plasma cell-free mitochondrial DNA(Baseline, Week 12, and Week 26)
- Change in urine cell-free mitochondrial DNA(Baseline, Week 12, and Week 26)
- Change in skin fingernail capillary density(Baseline, Week 12, and Week 26)
- Change in skin blood flow(Baseline, Week 12, and Week 26)
- Change in six-minute walk distance(Baseline, Week 12, and Week 26)
- Change in Handgrip Strength(Baseline, Week 12, and Week 26)
- Change in Timed Up and Go(Baseline, Week 12, and Week 26)
- Change in 30-second sit-to-stand(Baseline, Week 12, and Week 26)
研究者
Armin Ahmadi, PhD
Assistant Professor
University of California, San Diego