CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Placebos +1 moredrug
Likely dose
20mg sodium nitrite tidfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04405180
NCT04405180Phase 2Completed

Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age

Gladwin, Mark, MD·interventional·Posted May 28, 2020·Updated Oct 10, 2024

In Brief

A Phase 2 clinical trial evaluating Placebos and 20mg sodium nitrite tid for Aging and 2 related conditions. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 28, 2020
Enrollment StartApr 23, 2021
Primary CompletionJul 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.1 years ago

Interventions

Placebosdrug

Oral placebo capsule at a dose of 20 mg administered three times per day, during the day.

20mg sodium nitrite tiddrug

Oral, inorganic sodium nitrite capsule at a dose of 20 mg administered three times per day, during the day.