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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579693
Other study ID # STUDY00004998
Secondary ID R01DK101509
Status Completed
Phase Phase 2
First received
Last updated
Start date November 14, 2018
Est. completion date April 26, 2021

Study information

Verified date December 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date April 26, 2021
Est. primary completion date April 26, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 79 Years
Eligibility 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)

Study Design


Intervention

Dietary Supplement:
CoQ10
CoQ10 tablet
Nicotinamide riboside
NR tablet
Placebo
Sugar pill designed to mimic coQ10 and NR

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Aerobic Capacity- CoQ10 The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period. 6 weeks
Primary Work Efficiency The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale.. 6 weeks
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