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Nitrite Therapy for Aging (Nitrite Trial)
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.
- Aging
- Frailty
- Sedentary Lifestyle
Nitrite Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Nitrite Trial Design
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Who is running the clinical trial?
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- You have a serious and unstable long-term illness like cancer or advanced organ disease.You have a long-term condition that makes it difficult for you to be physically active or complete exercise tests.You have a serious condition affecting the blood vessels in your limbs or lungs.You are currently taking medications called organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors.You have a problem with alcohol or drug addiction and use them regularly.You are allergic to lidocaine or red dye.You have been taking oral corticosteroids or other medications that can affect your muscles for a long time.You have a very advanced stage of the disease.You don't exercise much, less than an hour per week.
- Group 1: 20 mg Sodium Nitrite TID Arm
- Group 2: Placebo Control Arm
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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