Nicotinamide Riboside to Improve Functioning in PAD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Six-minute walk distance
研究概览
简要总结
Among people with peripheral artery disease (PAD) age 50 and older, the investigators will test the hypothesis that PAD participants randomized to nicotinamide riboside (NR) will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 250 participants with PAD age 50 and older to one of two groups for six months: nicotinamide riboside vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Walking Impairment Questionnaire (WIQ) distance score, PROMIS Mobility score, calf muscle perfusion (measured by magnetic resonance arterial spin labeling (MRI ASL)), oxidative stress (measured by plasma oxidized LDL), NAD+ abundance in whole blood, 6-minute walk improvement by baseline whole blood NAD+ levels, and 6-minute walk distance at 4 weeks after intervention completion.
To achieve the specific aims, the study will randomize 250 participants age 50 and older with PAD to one of two groups: nicotinamide riboside vs placebo. Participants will be followed for six months, with an additional four-week follow-up period after completion of the study intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 50 and older.
- •2. Presence of peripheral artery disease (PAD). PAD will be defined as either: a. An ABI < 0.90 at baseline. b. Vascular lab evidence of PAD (such as a toe brachial pressure < 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities. c. An ABI of >0.90 and <1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
排除标准
- •1. Above- or below-knee amputation
- •2. Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain
- •3. Wheelchair confinement or requiring a walker to ambulate
- •4. Walking is limited by a symptom other than PAD
- •5. Current foot ulcer on bottom of foot
- •6. Failure to successfully complete the study run-in
- •7. Planned major surgery, coronary or leg revascularization during the next six months
- •8. Major surgery, coronary or leg revascularization, or major cardiovascular event in the previous three months
- •9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.]
- •10. Non-English speaking. The integrity of the clinical trial requires clear and effective communication for data collection and study interventions. The trial does not have sufficient staff members who are fluent in non-English languages, nor does it have the budget to translate all study materials into other languages.
- •11. Current participation in or completion of a clinical trial intervention in the previous three months. However, at investigator discretion, depending on the nature of the trial, when the intervention was administered, or whether the participant remains in long term follow-up, a potential participant formally enrolled in a clinical trial may be eligible.
- •12. Visual impairment that limits walking ability.
- •13. Participation in a supervised treadmill exercise program or in a cardiac rehabilitation program in the previous three months or who plan to begin a supervised treadmill exercise program or a cardiac rehabilitation program in the next six months.
- •14. Unstable angina.
- •15. Unwilling to participate in study intervention.
- •16. Allergy to nicotinamide riboside.
- •17. Potential participants who have taken a daily dose of 100 mg or more of nicotinamide riboside or niacin, 200 mg or more of vitamin B3, or nicotinamide mononucleotide (NMN) in the previous three months.
- •18. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
结局指标
主要结局
Six-minute walk distance
时间窗: Baseline to 6-months
Change in six-minute walk distance between baseline and 6-month follow-up.
次要结局
- Oxidative stress(Baseline to 6-month follow-up)
- NAD+(Baseline to 6-month follow-up)
- 6-minute walk(Baseline to four weeks after primary outcome measurement (i.e. 7-month follow-up))
- Walking Impairment Questionnaire (WIQ) distance score(Baseline to 6-month follow-up)
- PROMIS Mobility score.(Baseline to 6-month follow-up)
- Calf muscle perfusion(Baseline to 6-month follow-up)
研究者
Mary McDermott
Jeremiah Stamler Professor of Medicine
Northwestern University