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Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

NCT01681836 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-09-04

Study results available
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Summary

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.

Conditions

  • Focus of Study of Healthy Adults

Interventions

DRUG

15Nitrogen(15N)-labeled sodium nitrite

15Nitrogen(15N)-labeled sodium nitrite 20 mg once

DRUG

15Nitrogen(15N)-labeled sodium nitrate

15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once

Sponsors & Collaborators

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Kara S Hughan, MD · University of Pittsburgh

  • Mark T Gladwin, MD · University of Pittsburgh

  • Bret Goodpaster, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681836 on ClinicalTrials.gov