Sodium Nitrite to Treat Arterial Aging

University of Colorado Boulder (CU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Vascular Aging

Treatments: Drug: Sodium Nitrite; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02022670

R21HL107105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Sodium Nitrite 80 mg/d

Experimental group

Description:

80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks

Treatment:

Drug: Sodium Nitrite

Sodium Nitrite 160 mg/d

Experimental group

Description:

160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks

Treatment:

Drug: Sodium Nitrite