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Inorganic Nitrate

Nitrite Therapy for Aging (Nitrite Trial)

Phase 2
Waitlist Available
Research Sponsored by Gladwin, Mark, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week course of study drug supplementation, up to 16 weeks total
Awards & highlights

Summary

This trial is to determine the effect of nitrite therapy on mitochondrial energetics, skeletal muscle vascular function, and whole body physical function in older adults.

Eligible Conditions
  • Aging
  • Frailty
  • Sedentary Lifestyle

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-week course of study drug supplementation, up to 16 weeks total
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week course of study drug supplementation, up to 16 weeks total for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Skeletal muscle mitochondrial respiration State 3, Baseline to 12-week change
Secondary outcome measures
Change in cross-sectional area for each fiber type by skeletal muscle microscopy, Baseline to 12-week change
Change in mitochondrial content (area/section) by skeletal muscle microscopy, Baseline to 12-week change
Change in relative area composition of each muscle fiber type by skeletal muscle microscopy, Baseline to 12-week change
+2 more
Other outcome measures
Baseline to 12-week change in Peak oxygen uptake (VO2) achieved during progressive resistance exercise testing
Baseline to 12-week change in VO2 during steady state exercise
Baseline to 12-week change in duration of constant work rate exercise
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg Sodium Nitrite TID ArmExperimental Treatment1 Intervention
Subject is to receive active study drug three times per day during treatment (12 weeks +/- 5 days) period and then after the treatment period (up to 16 weeks total).
Group II: Placebo Control ArmPlacebo Group1 Intervention
Subject is to receive placebo three times per day during treatment period (12 weeks +/- 5 days) and then after the treatment testing period (up to 16 weeks total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
20mg sodium nitrite tid
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Gladwin, Mark, MDLead Sponsor
14 Previous Clinical Trials
355 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,872 Total Patients Enrolled
17 Trials studying Aging
3,805 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,179 Total Patients Enrolled
163 Trials studying Aging
80,033 Patients Enrolled for Aging

Media Library

Sodium Nitrite (Inorganic Nitrate) Clinical Trial Eligibility Overview. Trial Name: NCT04405180 — Phase 2
Aging Research Study Groups: 20 mg Sodium Nitrite TID Arm, Placebo Control Arm
Aging Clinical Trial 2023: Sodium Nitrite Highlights & Side Effects. Trial Name: NCT04405180 — Phase 2
Sodium Nitrite (Inorganic Nitrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04405180 — Phase 2
~18 spots leftby Jul 2025
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