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Sodium Nitrite to Treat Arterial Aging

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ClinicalTrials.gov Identifier: NCT02022670
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : June 17, 2015
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
TheraVasc Inc.
Information provided by (Responsible Party):
University of Colorado, Boulder

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vascular Aging
Interventions Drug: Placebo
Drug: Sodium Nitrite
Enrollment 33
Recruitment Details Healthy men and women ages 50-79 years free of overt cardiovascular or chronic diseases.
Pre-assignment Details  
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Hide Arm/Group Description Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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

Period Title: Overall Study
Started 11 10 12
Completed 10 10 11
Not Completed 1 0 1
Reason Not Completed
Adverse Event             1             0             1
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d Total
Hide Arm/Group Description Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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 of all reporting groups
Overall Number of Baseline Participants 11 10 12 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 12 participants 33 participants
62  (8) 60  (6) 64  (6) 62  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 12 participants 33 participants
Female
5
  45.5%
5
  50.0%
6
  50.0%
16
  48.5%
Male
6
  54.5%
5
  50.0%
6
  50.0%
17
  51.5%
1.Primary Outcome
Title Baseline and Week 10 Flow-Mediated Dilation
Hide Description 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.
Time Frame Baseline (Week 0), Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Hide Arm/Group Description:
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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 Number of Participants Analyzed 10 10 10
Mean (Standard Error)
Unit of Measure: %Change
Baseline 3.120  (0.528) 4.307  (0.501) 3.118  (0.483)
Week 10 3.740  (0.509) 6.833  (0.785) 4.609  (0.720)
2.Secondary Outcome
Title Baseline and Week 10 Plasma Nitrite Concentrations
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Hide Arm/Group Description:

inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks

Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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 Number of Participants Analyzed 10 10 11
Mean (Standard Error)
Unit of Measure: micromolar
Baseline 0.201  (0.066) 0.209  (0.053) 0.155  (0.044)
Week 10 0.261  (0.051) 0.412  (0.066) 0.369  (0.064)
3.Secondary Outcome
Title Baseline and Week 10 Aortic Pulse Wave Velocity
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Hide Arm/Group Description:

inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks

Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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 Number of Participants Analyzed 9 10 10
Mean (Standard Error)
Unit of Measure: cm/sec
Baseline 782  (35) 780  (55) 946  (62)
Week 10 774  (36) 845  (75) 942  (77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Hide Arm/Group Description Placebo: Sugar pill manufactured to mimic sodium nitrite capsules

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

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

All-Cause Mortality
Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Sodium Nitrite 80 mg/d Sodium Nitrite 160 mg/d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/11 (18.18%)   4/10 (40.00%)   4/12 (33.33%) 
General disorders       
headache  1/11 (9.09%)  0/10 (0.00%)  3/12 (25.00%) 
nausea  1/11 (9.09%)  0/10 (0.00%)  0/12 (0.00%) 
fatigue  0/11 (0.00%)  2/10 (20.00%)  2/12 (16.67%) 
dizziness/light-headedness  1/11 (9.09%)  1/10 (10.00%)  2/12 (16.67%) 
asymptomatic orthostatic hypotension  1/11 (9.09%)  1/10 (10.00%)  1/12 (8.33%) 
dry mouth  1/11 (9.09%)  0/10 (0.00%)  0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Allison DeVan
Organization: University of Colorado Boulder
Phone: 303-735-6410
Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02022670     History of Changes
Other Study ID Numbers: R21HL107105 ( U.S. NIH Grant/Contract )
First Submitted: December 13, 2013
First Posted: December 30, 2013
Results First Submitted: March 12, 2015
Results First Posted: June 17, 2015
Last Update Posted: July 15, 2015