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NCT04405180 · ClinicalTrials.gov registry record · Phase 2
Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age
A Phase 2 study of Aging and Frailty, sponsored by Gladwin, Mark, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04405180: Completed Phase 2 study of Aging and Frailty, sponsored by Gladwin, Mark, MD.
NCT04405180 is a Phase 2 study of Aging and Frailty that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 64 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04405180, a Phase 2 study of Aging and Frailty, has completed, sponsored by Gladwin, Mark, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sedentary adults. This investigator will take an integrative physiology approach to determine the effect of nitrite therapy on a comprehensive assessment of mitochondrial energetics, skeletal muscle vascular function, and whole body physical function (cardiorespiratory function, exercise endurance, strength, balance, and physical activity) and fatigability.
Primary Outcome
High resolution respirometry via Oroboros Oxygraph 2k is used to assess the effects of 12 weeks of inorganic nitrite vs placebo on skeletal muscle mitochondrial respiration from samples obtained via vastus lateralis muscle biopsy.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG 20mg sodium nitrite tid
Study Locations (1)
Pennsylvania
- University Of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-04-23 |
| Est. Completion | 2023-07-14 |
| Phase | Phase 2 |
What the finished NCT04405180 record still lists
NCT04405180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Aging appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT04405180 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04405180 about?
NCT04405180 is a clinical study titled "Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age". This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sedentary adults. This investigator will take an integrative physiology approach to determine the effect...
What is the current status of trial NCT04405180?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2021-04-23. Estimated completion is 2023-07-14.
What conditions does trial NCT04405180 study?
This clinical trial studies the following conditions: Aging, Frailty, Sedentary Lifestyle.
What interventions are being tested in trial NCT04405180?
The interventions under investigation include: Placebos (DRUG), 20mg sodium nitrite tid (DRUG).
Who is sponsoring clinical trial NCT04405180?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04405180 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aging
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04405180's enrollment target sits among peer trials
64 133rd of 262 higher than 129 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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