Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Orthopedic |
| Therapuetic Areas: | Nephrology / Urology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 30 - 79 |
| Updated: | 12/8/2018 |
| Start Date: | November 14, 2018 |
| End Date: | April 2020 |
| Contact: | Nicole Robinson, BS |
| Email: | nrr3@uw.edu |
| Phone: | 206-897-4749 |
Cross-over Randomized Controlled Trial of Coenzyme Q10 or Nicotinamide Riboside in Chronic Kidney Disease
Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This
process detrimentally impacts mobility, functional independence, and quality of life.
Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by
injuring mitochondria, the central energy producing units of cells.
Potential treatment options to restore mitochondrial function include aerobic and weight
bearing exercise and medications that directly improve mitochondrial energetics.
Unfortunately, exercise programs may be difficult to implement in people who have chronic
diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are
naturally occurring supplements that can directly improve mitochondrial efficiency. Both
compounds help mitochondria produce more energy while generating less waste.
The primary purpose of this study is to test whether coQ10 and NR can improve muscle function
among people with chronic kidney disease. What we learn in this study may help us better
understand the mechanisms of skeletal muscle impairment among people with kidney disease and
ultimately improve their ability to be active and independent.
process detrimentally impacts mobility, functional independence, and quality of life.
Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by
injuring mitochondria, the central energy producing units of cells.
Potential treatment options to restore mitochondrial function include aerobic and weight
bearing exercise and medications that directly improve mitochondrial energetics.
Unfortunately, exercise programs may be difficult to implement in people who have chronic
diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are
naturally occurring supplements that can directly improve mitochondrial efficiency. Both
compounds help mitochondria produce more energy while generating less waste.
The primary purpose of this study is to test whether coQ10 and NR can improve muscle function
among people with chronic kidney disease. What we learn in this study may help us better
understand the mechanisms of skeletal muscle impairment among people with kidney disease and
ultimately improve their ability to be active and independent.
Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney
disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing
evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a
key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify
mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide
riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore
substrate delivery to mitochondria, respectively.
Both processes have the potential to increase mitochondrial energy production with direct
consequences for many metabolic and physical processes, including:
- aerobic capacity
- work efficiency
- mitochondrial energetics
- fatigue
- physical function
- inflammation
- oxidative stress
- heart failure symptoms
- metabolomics
These outcomes will assessed in all study participants who enroll in the trial. Addressing
these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in
CKD and suggest future interventions that reduce morbidity and mortality.
This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR
treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo
each for six-weeks in random order with a 7-day washout between treatment periods. The
primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle
ergometry.
disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing
evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a
key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify
mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide
riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore
substrate delivery to mitochondria, respectively.
Both processes have the potential to increase mitochondrial energy production with direct
consequences for many metabolic and physical processes, including:
- aerobic capacity
- work efficiency
- mitochondrial energetics
- fatigue
- physical function
- inflammation
- oxidative stress
- heart failure symptoms
- metabolomics
These outcomes will assessed in all study participants who enroll in the trial. Addressing
these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in
CKD and suggest future interventions that reduce morbidity and mortality.
This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR
treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo
each for six-weeks in random order with a 7-day washout between treatment periods. The
primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle
ergometry.
Inclusion Criteria:
- Chronic kidney disease, defined in this study as an estimated glomerular filtration
rate (eGFR) of <50ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology
Collaboration equation
Exclusion Criteria:
- 6-minute walking distance >500meters
- Pregnancy
- Receiving renal replacement therapy (dialysis or kidney transplantation)
- Expectation to start dialysis within 6 months
- Insulin dependent diabetes mellitus
- Severe anemia: hemoglobin <8 g/dL
- Hyperkalemia: K >5.7 mEq/L
- Weight >300 lbs
- HIV
- End stage liver disease with cirrhosis
- Oxygen-dependent Chronic Obstructive Pulmonary Disease (COPD)
- Unable to walk unassisted from room to room in own house
- Institutionalization, or inability to consent
- Use of immunosuppressive medications (i.e. steroids, calcineurin inhibitors)
- Malignancy requiring active treatment or currently under surveillance (at the
discretion of the investigator)
- Cardiac pacemaker
- Current participation in another interventional trial
- Non-English speaking
- Hospitalization for heart attack, stroke, or unstable cardiac chest pain within the
previous 3 months (e.g. myocardial infarction, unstable angina, cerebrovascular
accident)
- Any medical condition that the investigator feels would prevent the participant from
safely completing the exercise-based outcome measurements.
- Baseline systolic blood pressure >170 or diastolic blood pressure >100
- Persistent or permanent uncontrolled arrhythmia (at the discretion of the
investigator)
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