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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

Nitrite Trial 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

Nitrite Trial 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

Nitrite 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
2,686 Previous Clinical Trials
6,930,802 Total Patients Enrolled
17 Trials studying Aging
3,805 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,661 Previous Clinical Trials
28,005,050 Total Patients Enrolled
160 Trials studying Aging
75,929 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA endorse 20mg sodium nitrite taken three times daily?

"Our team at Power scored the safety of 20 mg sodium nitrite taken three times a day as a 2 due to existing evidence on its safety, but not yet any suggesting efficacy in Phase 2 trials."

Answered by AI

What is the numerical scope of the individuals partaking in this research endeavor?

"Affirmative. The clinicaltrials.gov entry for this trial indicates that it is presently recruiting participants, with 70 spots available at a single location since its posting on April 23rd 2021 and last update on June 6th 2022."

Answered by AI

Are there any vacancies still available in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment commenced on April 23rd 2021 and is currently recruiting participants. A total of 70 volunteers are needed at a single center for the study's completion."

Answered by AI

To what extent has a 20mg dosage of sodium nitrite been applied in other clinical trials?

"Currently, 4 trials are conducted to research the efficacy of 20mg sodium nitrite taken three times a day. None of them have advanced their clinical stages beyond Phase 2 and most studies occur in Bronx, New york. However, there also exists 7 other medical sites that conduct this research."

Answered by AI

Is this the inaugural endeavor to evaluate this particular treatment?

"Since 2016, 20mg sodium nitrite tid has been under investigation. The first trial was initiated and sponsored by Mast Therapeutics Inc., and following the successful Phase 1 & 2 trials involving 35 patients, it received drug approval. Presently, 4 active studies are taking place across two cities in one nation."

Answered by AI
~20 spots leftby Apr 2025