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Trial record 34 of 535 for:    NITRATE ION

Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT01983826
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Darren P Casey, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Peripheral Artery Disease
Interventions Dietary Supplement: Sodium Nitrate
Other: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Nitrate (NaNO3) Placebo
Hide Arm/Group Description Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks
Period Title: Overall Study
Started 13 8
Completed 13 8
Not Completed 0 0
Arm/Group Title Sodium Nitrate (NaNO3) Placebo Total
Hide Arm/Group Description Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 13 8 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 8 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  15.4%
3
  37.5%
5
  23.8%
>=65 years
11
  84.6%
5
  62.5%
16
  76.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 8 participants 21 participants
73  (9) 69  (10) 72  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 8 participants 21 participants
Female
6
  46.2%
6
  75.0%
12
  57.1%
Male
7
  53.8%
2
  25.0%
9
  42.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 8 participants 21 participants
13
 100.0%
8
 100.0%
21
 100.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants 8 participants 21 participants
29.2  (5.9) 28.1  (3.6) 28.8  (5.1)
Ankle-brachial index (ABI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 13 participants 8 participants 21 participants
0.76  (0.21) 0.81  (0.14) 0.78  (0.18)
[1]
Measure Description:

Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg may be a symptom of peripheral artery disease (PAD) or a blockage in the leg. Ranges for ABI values are:

No blockage (1.0 to 1.4)

Borderline blockage (0.91 to 0.99). An ankle-brachial index number is this range indicates that you have borderline PAD.

PAD (less than 0.90). An ankle-brachial index number in this range is considered abnormal and indicates a diagnosis of PAD.

Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 13 participants 8 participants 21 participants
136  (15) 132  (13) 135  (14)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 13 participants 8 participants 21 participants
72  (9) 77  (10) 74  (10)
1.Primary Outcome
Title Change in Vasodilator Capacity
Hide Description Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).
Time Frame Pre and post 8 weeks of dietary nitrate supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
Calf blood flow measures were only performed in 11 of the subjects in the NaNO3 group and 7 of the subjects in the Placebo group.
Arm/Group Title Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Hide Arm/Group Description:
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Overall Number of Participants Analyzed 13 13 8 8
Mean (Standard Deviation)
Unit of Measure: ml/100ml tissue/min
Peak forearm Blood Flow Number Analyzed 13 participants 13 participants 8 participants 8 participants
16.2  (6.6) 16.4  (4.2) 16.5  (5.2) 14.2  (7.2)
Peak calf Blood Flow Number Analyzed 11 participants 11 participants 7 participants 7 participants
11.6  (4.9) 14.1  (5.1) 13.1  (3.5) 11.9  (3.7)
2.Primary Outcome
Title Change in Arterial Stiffness
Hide Description ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).
Time Frame Pre and post 8 weeks of dietary nitrate supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
We were only able to obtain quality PWV measures in 11 subjects in the sodium nitrate group and 6 in the placebo group.
Arm/Group Title Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Hide Arm/Group Description:
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Overall Number of Participants Analyzed 11 11 6 6
Mean (Standard Deviation)
Unit of Measure: m/sec
13.8  (3.4) 12.8  (2.9) 10.5  (3.1) 11.0  (3.7)
3.Primary Outcome
Title Change in Functional Capacity - Distance Walked in 6 Minutes
Hide Description 6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation.
Time Frame Pre and post 8 weeks of dietary nitrate supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Hide Arm/Group Description:
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Overall Number of Participants Analyzed 13 13 8 8
Mean (Standard Deviation)
Unit of Measure: meters
387  (90) 425  (82) 423  (56) 427  (66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Hide Arm/Group Description Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
All-Cause Mortality
Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Nitrate (NaNO3) Pre Sodium Nitrate (NaNO3) Post Placebo - Pre Placebo - Post
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/8 (0.00%)   0/8 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Darren P. Casey
Organization: University of Iowa
EMail: darren-casey@uiowa.edu
Layout table for additonal information
Responsible Party: Darren P Casey, University of Iowa
ClinicalTrials.gov Identifier: NCT01983826     History of Changes
Other Study ID Numbers: 201307745
13GRNT16490002 ( Other Grant/Funding Number: American Heart Association )
First Submitted: October 28, 2013
First Posted: November 14, 2013
Results First Submitted: October 9, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019