Sodium Nitrite to Treat Arterial Aging

Vascular Aging Clinical Trial

Official title:

Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022670
• Other study ID #: R21HL107105
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 13, 2013
• Last updated: June 18, 2015
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.

Description:

The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• 50-79 years of age

• Ability to provide informed consent

• Score greater than 22 on the mini mental state exam

• Blood pressure greater than 100/60 mmHg for past 3 months

Exclusion Criteria:

• Are taking any of the following medications/drugs: hormone replacement therapy, anti-hypertensives, nitrates, nervous system depressants, allopurinol, phosphodiesterase-5 inhibitors, blood thinners

• Are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or unstable cardiovascular disease

• Are hypersensitive to nitrates or nitrites

• Have glucose-6-phosphate dehydrogenase deficiency

• Have blood methemoglobin greater than 2%

• Have a BMI greater than 40 kg/m^2

• Have a baseline FMD of greater than 6%

• Have not been post-menopausal for at least 1 year

• Perform regular vigorous aerobic/endurance exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Aging

Intervention

Drug:
• Placebo
Sugar pill manufactured to mimic sodium nitrite capsules
• Sodium Nitrite
80 mg/d or 160 mg/d

Locations

Country	Name	City	State
United States	Clinical Translational Research Center	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	TheraVasc Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline and Week 10 Flow-Mediated Dilation	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.	Baseline (Week 0), Week 10	No
Secondary	Baseline and Week 10 Plasma Nitrite Concentrations		Baseline (Week 0), Week 10	No
Secondary	Baseline and Week 10 Aortic Pulse Wave Velocity		Baseline (Week 0), Week 10	No

External Links

•   Integrative Physiology of Aging Laboratory Website