Trial Outcomes & Findings for NAD+ and Exercise in FA (NCT NCT04192136)
NCT ID: NCT04192136
Last Updated: 2026-03-11
Results Overview
Peak V02 will be assessed by completion of an incremental symptom-limited cardio-pulmonary Exercise Stress Test (EST) on a recumbent leg cycle ergometer. The index is based on the change in peak V02 given in liters per minute (L/min), and a higher value indicates greater oxygen uptake.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Baseline to 12 Weeks
Results posted on
2026-03-11
Participant Flow
Once consent was obtained, participants were reviewed for eligibility and inclusion in the trial. Individuals meeting criteria were randomized. In total, 75 participants signed informed consent. There was 1 withdrawal of consent prior to in-person screening (ankle injury). 74 completed in-person screening. 8 were considered ineligible after screening due to: not reaching cadence during CPET (7) and not able to complete blood draw (1)
Participant milestones
| Measure |
Nicotinamide Riboside (NR)
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Patients Not Randomized
Patients who signed consent but did not meet eligibility for the study, and did not proceed to randomization
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
16
|
16
|
9
|
|
Overall Study
COMPLETED
|
17
|
17
|
16
|
16
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Nicotinamide Riboside (NR)
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Patients Not Randomized
Patients who signed consent but did not meet eligibility for the study, and did not proceed to randomization
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
could not reach required cadence during CPET at Baseline Visit
|
0
|
0
|
0
|
0
|
7
|
|
Overall Study
not able to complete blood draw at Baseline visit
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
NAD+ and Exercise in FA
Baseline characteristics by cohort
| Measure |
Nicotinamide Riboside (NR)
n=17 Participants
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
n=17 Participants
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
n=16 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
n=16 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
17.1 years
n=9 Participants
|
19.6 years
n=9 Participants
|
18.5 years
n=18 Participants
|
18.2 years
n=15 Participants
|
18.1 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
9 Participants
n=15 Participants
|
29 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
11 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
7 Participants
n=15 Participants
|
37 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=9 Participants
|
14 Participants
n=9 Participants
|
15 Participants
n=18 Participants
|
14 Participants
n=15 Participants
|
56 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
13 Participants
n=9 Participants
|
15 Participants
n=18 Participants
|
13 Participants
n=15 Participants
|
55 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
8 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=9 Participants
|
17 participants
n=9 Participants
|
16 participants
n=18 Participants
|
16 participants
n=15 Participants
|
66 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 WeeksPopulation: One individual in the Placebo group did not attempt a CPET at week 12 because of an intercurrent foot injury, and thus did not contribute to the analysis for the main outcome
Peak V02 will be assessed by completion of an incremental symptom-limited cardio-pulmonary Exercise Stress Test (EST) on a recumbent leg cycle ergometer. The index is based on the change in peak V02 given in liters per minute (L/min), and a higher value indicates greater oxygen uptake.
Outcome measures
| Measure |
Nicotinamide Riboside (NR)
n=17 Participants
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
n=16 Participants
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
n=16 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
n=16 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
|---|---|---|---|---|
|
Within-Participant Change in Peak V02 (Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing)
|
0.06 L/min
Interval -0.06 to 0.14
|
-0.06 L/min
Interval -0.15 to 0.08
|
0.1 L/min
Interval 0.02 to 0.23
|
0.03 L/min
Interval -0.06 to 0.22
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: Two individuals each had one result missing due to not completing the full OGTT testing, and thus did not contribute to the analysis for the secondary outcome
Whole Body Insulin Sensitivity (Si) will be assessed by completion of a stable isotope tracer-enhanced Oral Glucose Tolerance Test (OGTT). Samples will be collected at 10 time points for analysis. The unit of measure is based on the change insulin values given in microunits per milliliter (μU/mL) and those of glucose, in milligrams per deciliter, and a higher value indicates greater insulin sensitivity. The whole body insulin sensitivity index (WBISI), also known as the Matsuda index or composite ISI, is dimensionless (unitless).
Outcome measures
| Measure |
Nicotinamide Riboside (NR)
n=17 Participants
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
n=17 Participants
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
n=14 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
n=16 Participants
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
|---|---|---|---|---|
|
Within-Participant Change in Whole Body Insulin Sensitivity (Si)
|
-0.23 Unitless Index Value
Interval -0.48 to 0.38
|
-0.11 Unitless Index Value
Interval -1.08 to 0.35
|
-0.31 Unitless Index Value
Interval -0.92 to 0.41
|
-0.51 Unitless Index Value
Interval -1.07 to 0.07
|
Adverse Events
Nicotinamide Riboside (NR)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Exercise Intervention and NR
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Exercise Intervention and Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotinamide Riboside (NR)
n=17 participants at risk
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
|
Placebo
n=17 participants at risk
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight \> 72 kg: 900 mg po qd x 12 wks.
For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Placebo: The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
|
Exercise Intervention and NR
n=16 participants at risk
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
Exercise Intervention and Placebo
n=16 participants at risk
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Nicotinamide Riboside: Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside, distributed by ChromaDex, Inc., Irvine, CA.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
Exercise Intervention: On aerobic days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
On resistance days, subjects will be instructed to complete circuits of resistance exercises. Training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group.
|
|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
35.3%
6/17 • Number of events 7 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
41.2%
7/17 • Number of events 7 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
31.2%
5/16 • Number of events 5 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
31.2%
5/16 • Number of events 5 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Injury, poisoning and procedural complications
Injury and Procedural Complications
|
41.2%
7/17 • Number of events 9 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
52.9%
9/17 • Number of events 15 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
18.8%
3/16 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
25.0%
4/16 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Infections and infestations
Investigations
|
23.5%
4/17 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
23.5%
4/17 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
25.0%
4/16 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
41.2%
7/17 • Number of events 9 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
47.1%
8/17 • Number of events 12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
43.8%
7/16 • Number of events 8 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
50.0%
8/16 • Number of events 10 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
5.9%
1/17 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
58.8%
10/17 • Number of events 12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
35.3%
6/17 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
31.2%
5/16 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
43.8%
7/16 • Number of events 8 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Nervous system disorders
Nervous System Disorders
|
52.9%
9/17 • Number of events 14 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
29.4%
5/17 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
25.0%
4/16 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Psychiatric disorders
Psychiatric Disorders
|
35.3%
6/17 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
11.8%
2/17 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
17.6%
3/17 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
23.5%
4/17 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
52.9%
9/17 • Number of events 16 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
52.9%
9/17 • Number of events 14 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
56.2%
9/16 • Number of events 13 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
43.8%
7/16 • Number of events 10 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Gastrointestinal disorders
GI Disorders
|
58.8%
10/17 • Number of events 12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
41.2%
7/17 • Number of events 11 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
43.8%
7/16 • Number of events 9 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
31.2%
5/16 • Number of events 6 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Cardiac disorders
Cardiac Disorders
|
5.9%
1/17 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
11.8%
2/17 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
18.8%
3/16 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
Eye disorders
Eye Disorders
|
23.5%
4/17 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
11.8%
2/17 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
0.00%
0/16 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
12.5%
2/16 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
|
General disorders
General Disorders
|
52.9%
9/17 • Number of events 14 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
41.2%
7/17 • Number of events 7 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
25.0%
4/16 • Number of events 5 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
25.0%
4/16 • Number of events 5 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 24 Weeks).
Adverse events (AEs) were tracked systematically. Only Grade 1 and Grade 2 AEs occurred. Non-randomized participants were not assessed for deaths or adverse events
|
Additional Information
Shana McCormack, MD
Children's Hospital of Philadelphia
Phone: 617-596-9067
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place