Trial Outcomes & Findings for Vitamin C in Atrial Fibrillation Ablation (NCT NCT03148236)
NCT ID: NCT03148236
Last Updated: 2019-04-16
Results Overview
Change in Kidney Function
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 24 hours
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Vitamin C
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
Placebo
Placebo: 50mL infused over 30 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin C in Atrial Fibrillation Ablation
Baseline characteristics by cohort
| Measure |
Vitamin C
n=10 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
60.5 years
n=99 Participants
|
65 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursChange in Kidney Function
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=10 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Creatinine Levels
|
-0.1 mg/dL
Interval -0.2 to 0.0
|
-0.1 mg/dL
Interval -0.2 to -0.1
|
PRIMARY outcome
Timeframe: baseline to 24 hoursChange in plasma levels of ascorbic acid
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=10 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Plasma Levels of Ascorbic Acid
|
-4 micromolar
Interval -8.0 to -1.0
|
267 micromolar
Interval 98.0 to 597.0
|
PRIMARY outcome
Timeframe: baseline to 24 hoursBiomarker of inflammation
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=10 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in hsCRP
|
16.01 mg/L
Interval 9.4 to 29.29
|
5.31 mg/L
Interval 4.48 to 7.92
|
PRIMARY outcome
Timeframe: baseline to 24 hoursBiomarker of inflammation
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Interleukin (IL-6)
|
6.6 pg/mL
Interval 2.6 to 12.1
|
13.3 pg/mL
Interval 6.6 to 29.4
|
PRIMARY outcome
Timeframe: baseline to 24 hoursBiomarker of blood vessel damage
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Von Willebrand Factor (vWF)
|
0.4 micrograms/mL
Interval -2.5 to 2.5
|
0.4 micrograms/mL
Interval -1.3 to 4.8
|
PRIMARY outcome
Timeframe: Baseline to 30 daysChange in kidney function
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Creatinine Levels
|
0.1 mg/dL
Interval 0.0 to 0.1
|
0 mg/dL
Interval -0.1 to 0.0
|
PRIMARY outcome
Timeframe: Baseline to 30 daysChange in plasma ascorbic acid level
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Plasma Ascorbic Acid Level
|
-5 micromolar
Interval -12.0 to 20.0
|
3 micromolar
Interval -10.0 to 21.0
|
PRIMARY outcome
Timeframe: baseline to 30 daysBiomarker of inflammation
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in hsCRP
|
-0.64 mg/L
Interval -2.7 to -0.15
|
-0.30 mg/L
Interval -1.16 to 0.32
|
PRIMARY outcome
Timeframe: baseline to 30 daysBiomarker of inflammation
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Interleukin (IL-6)
|
0.1 pg/mL
Interval -0.6 to 1.1
|
0 pg/mL
Interval -0.7 to 0.4
|
PRIMARY outcome
Timeframe: baseline to 30 daysBiomarker of blood vessel damage
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=9 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Change in Von Willebrand Factor (vWF)
|
-3.8 micrograms/mL
Interval -7.5 to 0.6
|
-2.3 micrograms/mL
Interval -3.7 to 1.7
|
SECONDARY outcome
Timeframe: baseline to 24 hoursSum of pain scores every six hours for the 24 hour period following ablation measured on a visual analog scale scored on a level from zero (no pain) to 10 (maximum pain)
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: 50mL infused over 30 minutes
|
Vitamin C
n=10 Participants
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
|---|---|---|
|
Post Procedural Pain
|
0.3 score on a scale
Interval 0.0 to 1.0
|
4.5 score on a scale
Interval 1.3 to 9.8
|
Adverse Events
Vitamin C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin C
n=10 participants at risk
Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
|
Placebo
n=10 participants at risk
Placebo: 50mL infused over 30 minutes
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
10.0%
1/10 • Number of events 1 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place