Trial Outcomes & Findings for Sodium Nitrite to Treat Arterial Aging (NCT NCT02022670)
NCT ID: NCT02022670
Last Updated: 2015-07-15
Results Overview
Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline (Week 0), Week 10
Results posted on
2015-07-15
Participant Flow
Healthy men and women ages 50-79 years free of overt cardiovascular or chronic diseases.
Participant milestones
| Measure |
Placebo
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
Sodium Nitrite to Treat Arterial Aging
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
n=10 Participants
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
n=12 Participants
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 6 • n=7 Participants
|
64 years
STANDARD_DEVIATION 6 • n=5 Participants
|
62 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 10Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
n=10 Participants
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
n=10 Participants
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
Baseline and Week 10 Flow-Mediated Dilation
Baseline
|
3.120 %Change
Standard Error 0.528
|
4.307 %Change
Standard Error 0.501
|
3.118 %Change
Standard Error 0.483
|
|
Baseline and Week 10 Flow-Mediated Dilation
Week 10
|
3.740 %Change
Standard Error 0.509
|
6.833 %Change
Standard Error 0.785
|
4.609 %Change
Standard Error 0.720
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 10Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
n=10 Participants
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
n=11 Participants
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
Baseline and Week 10 Plasma Nitrite Concentrations
Baseline
|
0.201 micromolar
Standard Error 0.066
|
0.209 micromolar
Standard Error 0.053
|
0.155 micromolar
Standard Error 0.044
|
|
Baseline and Week 10 Plasma Nitrite Concentrations
Week 10
|
0.261 micromolar
Standard Error 0.051
|
0.412 micromolar
Standard Error 0.066
|
0.369 micromolar
Standard Error 0.064
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 10Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
n=10 Participants
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
n=10 Participants
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
Baseline and Week 10 Aortic Pulse Wave Velocity
Baseline
|
782 cm/sec
Standard Error 35
|
780 cm/sec
Standard Error 55
|
946 cm/sec
Standard Error 62
|
|
Baseline and Week 10 Aortic Pulse Wave Velocity
Week 10
|
774 cm/sec
Standard Error 36
|
845 cm/sec
Standard Error 75
|
942 cm/sec
Standard Error 77
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sodium Nitrite 80 mg/d
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sodium Nitrite 160 mg/d
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
|
Sodium Nitrite 80 mg/d
n=10 participants at risk
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
Sodium Nitrite 160 mg/d
n=12 participants at risk
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d
|
|---|---|---|---|
|
General disorders
headache
|
9.1%
1/11
|
0.00%
0/10
|
25.0%
3/12
|
|
General disorders
nausea
|
9.1%
1/11
|
0.00%
0/10
|
0.00%
0/12
|
|
General disorders
fatigue
|
0.00%
0/11
|
20.0%
2/10
|
16.7%
2/12
|
|
General disorders
dizziness/light-headedness
|
9.1%
1/11
|
10.0%
1/10
|
16.7%
2/12
|
|
General disorders
asymptomatic orthostatic hypotension
|
9.1%
1/11
|
10.0%
1/10
|
8.3%
1/12
|
|
General disorders
dry mouth
|
9.1%
1/11
|
0.00%
0/10
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place