Trial Outcomes & Findings for Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease (NCT NCT03579693)
NCT ID: NCT03579693
Last Updated: 2023-01-10
Results Overview
The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Placebo, Then Nicotinamide Riboside, Then CoQ10
Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.
|
Placebo, Then CoQ10, Then Nicotinamide Riboside
Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.
|
Nicotinamide Riboside, Then Placebo, Then CoQ10
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.
|
Nicotinamide Riboside, Then CoQ10, Then Placebo
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks.
|
CoQ10, Then Placebo, Then Nicotinamide Riboside
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.
|
CoQ10, Then Nicotinamide Riboside, Then Placebo
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks.
|
|---|---|---|---|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
4
|
5
|
5
|
4
|
4
|
4
|
|
First Intervention (6 Weeks)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout (1 Week)
STARTED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Washout (1 Week)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Second Intervention (6 Weeks)
COMPLETED
|
4
|
4
|
5
|
4
|
4
|
3
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Washout (1 Week)
STARTED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Second Washout (1 Week)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Second Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (6 Weeks)
STARTED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Third Intervention (6 Weeks)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
3
|
|
Third Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Placebo, Then Nicotinamide Riboside, Then CoQ10
n=4 Participants
Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.
|
Placebo, Then CoQ10, Then Nicotinamide Riboside
n=5 Participants
Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.
|
Nicotinamide Riboside, Then Placebo, Then CoQ10
n=5 Participants
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.
|
Nicotinamide Riboside, Then CoQ10, Then Placebo
n=4 Participants
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks.
|
CoQ10, Then Placebo, Then Nicotinamide Riboside
n=4 Participants
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.
|
CoQ10, Then Nicotinamide Riboside, Then Placebo
n=4 Participants
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 16.3 • n=4 Participants
|
64.0 years
STANDARD_DEVIATION 7.5 • n=21 Participants
|
58.2 years
STANDARD_DEVIATION 22.6 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
eGFR per 2021 CKD-EPI
|
33.6 mL/min/1.73m^2
STANDARD_DEVIATION 10.5 • n=5 Participants
|
39.3 mL/min/1.73m^2
STANDARD_DEVIATION 10.1 • n=7 Participants
|
32.6 mL/min/1.73m^2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
34.6 mL/min/1.73m^2
STANDARD_DEVIATION 10.5 • n=4 Participants
|
45.2 mL/min/1.73m^2
STANDARD_DEVIATION 8.0 • n=21 Participants
|
36.0 mL/min/1.73m^2
STANDARD_DEVIATION 4.5 • n=8 Participants
|
37.0 mL/min/1.73m^2
STANDARD_DEVIATION 9.0 • n=8 Participants
|
|
Body mass index
|
27.9 kg/m^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 4.6 • n=4 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 2.7 • n=21 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 8.4 • n=8 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.2 • n=8 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Randomized participants that completed cycle ergometry following each treatment period.
The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.
Outcome measures
| Measure |
CoQ10
n=24 Participants
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks
CoQ10: CoQ10 tablet
|
Nicotinamide Riboside
n=25 Participants
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks
|
Placebo
n=25 Participants
Placebo, inactive sugar pill for 6 weeks
|
|---|---|---|---|
|
Maximal Aerobic Capacity- CoQ10
|
21.4 mL/min/kg
Standard Deviation 4.7
|
20.7 mL/min/kg
Standard Deviation 4.7
|
20.7 mL/min/kg
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Includes participants randomized and treated who complete cycle ergometry at the end of the corresponding treatment period.
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..
Outcome measures
| Measure |
CoQ10
n=24 Participants
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks
CoQ10: CoQ10 tablet
|
Nicotinamide Riboside
n=25 Participants
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks
|
Placebo
n=25 Participants
Placebo, inactive sugar pill for 6 weeks
|
|---|---|---|---|
|
Work Efficiency
|
33.3 Percent difference
Standard Deviation 4.2
|
32.5 Percent difference
Standard Deviation 5.1
|
33.1 Percent difference
Standard Deviation 5.2
|
Adverse Events
CoQ10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotinamide Riboside
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CoQ10
n=25 participants at risk
Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks
|
Nicotinamide Riboside
n=25 participants at risk
Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks
|
Placebo
n=25 participants at risk
Placebo, inactive sugar pill for 6 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory illness
|
0.00%
0/25 • For each treatment arm, adverse events are reported from the start of the treatment until the next visit (approximately 6 weeks total for each treatment).
Definitions used were consistent with clinicaltrials.gov. At each visit potential adverse events were assessed by participant interview.
|
4.0%
1/25 • Number of events 1 • For each treatment arm, adverse events are reported from the start of the treatment until the next visit (approximately 6 weeks total for each treatment).
Definitions used were consistent with clinicaltrials.gov. At each visit potential adverse events were assessed by participant interview.
|
8.0%
2/25 • Number of events 2 • For each treatment arm, adverse events are reported from the start of the treatment until the next visit (approximately 6 weeks total for each treatment).
Definitions used were consistent with clinicaltrials.gov. At each visit potential adverse events were assessed by participant interview.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place