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Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

G

Gladwin, Mark, MD

Status and phase

Completed
Phase 1

Conditions

Focus of Study of Healthy Adults

Treatments

Drug: 15Nitrogen(15N)-labeled sodium nitrite
Drug: 15Nitrogen(15N)-labeled sodium nitrate

Study type

Interventional

Identifiers

NCT01681836
PRO11120134

Details and patient eligibility

About

This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.

Full description

Preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. New findings suggest an effect of nitrate and nitrite therapy in the regulation of glucose-insulin homeostasis. Development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway.

For this reason, development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway. This study aims to establish the pharmacokinetics, metabolism and interconversion of nitrate to nitrite and nitrite to nitric oxide in vivo in healthy adult normal volunteers.

Enrollment

11 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18-60 years
  • Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg

Exclusion criteria

  • Positive urine pregnancy test or breastfeeding
  • Concurrent use of medications affecting glucose or lipid metabolism
  • Recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill, intrauterine device, DepoProvera)
  • Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
  • Current use of phosphodiesterase 5 inhibitors or organic nitrates
  • Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc
  • Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
  • Smoker

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Oral 15N-labeled sodium nitrate
Experimental group
Description:
Oral sodium nitrate 1,000 mg once first, then washout followed by oral sodium nitrite 20 mg once
Treatment:
Drug: 15Nitrogen(15N)-labeled sodium nitrate
Drug: 15Nitrogen(15N)-labeled sodium nitrite
Oral 15N-labeled sodium nitrite
Experimental group
Description:
Oral sodium nitrite 20 mg once first, then washout followed by oral sodium nitrate 1,000 mg once
Treatment:
Drug: 15Nitrogen(15N)-labeled sodium nitrate
Drug: 15Nitrogen(15N)-labeled sodium nitrite

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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