CLINICAL TRIAL

20mg sodium nitrite tid for Frailty

Recruiting · 65+ · All Sexes · Pittsburgh, PA

This study is evaluating whether nitrite therapy may have positive impacts for individuals with mitochondrial dysfunction.

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About the trial for Frailty

Eligible Conditions
Frailty · Sedentary Lifestyle · Aging

Treatment Groups

This trial involves 2 different treatments. 20mg Sodium Nitrite Tid is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
20mg sodium nitrite tid
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebos
DRUG

Eligibility

This trial is for patients born any sex aged 65 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
individuals had an increased incidence of CVD, CHD, and all-cause mortality compared with those who reported >1 hour/week of exercise activity show original
prior to the planned study intervention The subject is clinically stable and has not had to go to the hospital or had any invasive cardiac procedures in the last 6 weeks. show original
Age ≥70 years
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12-week course of study drug supplementation, up to 16 weeks total
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12-week course of study drug supplementation, up to 16 weeks total.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 20mg sodium nitrite tid will improve 1 primary outcome, 5 secondary outcomes, and 9 other outcomes in patients with Frailty. Measurement will happen over the course of 12-week course of study drug supplementation, up to 16 weeks total.

Vector Magnitude Counts - Physical activity (accelerometry)
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Using an Actigraph accelerometry device on the participant's wrist, will assess daily vector magnitude counts and its change with 12-weeks (up to 16-weeks) of inorganic nitrite supplementation vs placebo. Higher number of counts note improvement.
Handgrip Strength, Baseline to 12-week change
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Will assess handgrip strength in the dominant hand, and its change after 12-weeks (up to 16-weeks) of inorganic nitrite supplementation vs placebo. Higher score shows improvement.
Short Physical Performance Battery, Baseline to 12-week change
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Will assess SPPB Score and its change after 12-weeks (up to 16-weeks) of inorganic nitrite supplementation vs placebo. Higher score shows improvement.
Change in mitochondrial content (area/section) by skeletal muscle microscopy, Baseline to 12-week change
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Using microscopy and immmunofluorescence, we will measure the cross-sectional area for each fiber type, relative fiber type number, and relative area composition of each muscle fiber type and mitochondrial content (area/section) after 12 weeks of inorganic nitrite supplementation vs placebo.
Skeletal Muscle adenosine triphosphate (ATP) production, Baseline to 12-week change
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Using phosphorus-magnetic resonance spectroscopy, we will measure ATP production and how it will change after 12 weeks (up to 16 weeks) of inorganic nitrite supplementation vs placebo.
Steps - Physical activity (accelerometry)
12-WEEK COURSE OF STUDY DRUG SUPPLEMENTATION, UP TO 16 WEEKS TOTAL
Using an Actigraph accelerometry device on the participant's wrist, will assess daily steps and its change with 12-weeks (up to 16-weeks) of inorganic nitrite supplementation vs placebo. Higher number of steps note improvement.
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Who is running the study

Principal Investigator
D. F.
Prof. Daniel Forman, MD
University of Pittsburgh

Patient Q & A Section

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

What are the signs of frailty?

The signs of frailty are associated with a wide range of physical impairment, with the strongest signs of frailty associated with the earliest onset of aging pathology and the most severe disabilities. The signs of frailty may be used in the future to complement other frailty indicators. The use of these indicators could help identify persons at higher risk of being frail and possibly could allow us to target people for screening and for developing interventions that could potentially delay and potentially prevent frailty and related health problems.

Anonymous Patient Answer

How many people get frailty a year in the United States?

The prevalence of physical or cognitive frailty is high. The prevalence of both types is positively and non-linearly associated with functional level. More research is needed assessing how frailty is associated with both physical and cognitive health status in older adults.

Anonymous Patient Answer

Can frailty be cured?

Frailty and its associated factors are prevalent in older people, yet treatment of symptoms for frailty does not seem to produce symptomatic improvements. Further research is needed to determine whether interventions can improve prognosis.

Anonymous Patient Answer

What are common treatments for frailty?

The most prevalent treatment for frailty are medications. The medication most commonly used was benzodiazepines followed by antidepressants followed by antipsychotics. The most commonly used medications for frailty were antidepressants, anxiolytics, antihypertensives, antidiabetics or antihyperglycaemic agents, sedatives or hypnotics, and osteoporosis drugs. A Cochrane systematic review in 2008 found the most commonly used treatments were benzodiazepines and antidepressants based on moderate-strength evidence.

Anonymous Patient Answer

What is frailty?

In a frail population, prevalence of multimorbidity and concomitant use of medications was high. The high prevalence would render frailty a candidate criterion for an integrated approach to the multidisciplinary management of older patients.

Anonymous Patient Answer

What causes frailty?

frail elders have similar, or fewer, adverse health outcomes than non-frail elders. It is imperative that interventions be focused on reducing the risk of non-health outcomes in frail elders.

Anonymous Patient Answer

What are the common side effects of 20mg sodium nitrite tid?

20mg sodium nitrite tid is a safe and well-tolerated standard therapy for both short and longterm treatment of decompensated heart failure. This article focuses on the side effects of the nitrite.

Anonymous Patient Answer

How does 20mg sodium nitrite tid work?

20mg NO₂ tid increased NO levels in the whole blood of healthy volunteers (mean, 1.5-fold; P=.0001). Moreover, NO₂-dependent vasodilation of the brachial artery was preserved during acute hypoxemia (mean, 26%; P=.003). In conclusion, 20mg NO₂ tid may be a potentially useful treatment of arterial hypertension during hypoxemia.

Anonymous Patient Answer

What is the primary cause of frailty?

Among frail elderly, frailty precedes and is not associated with a single, primary cause of diminished physical function; however, a range of multifactorial factors may contribute to frailty and, to some extent, the development of functional decline.

Anonymous Patient Answer

What are the latest developments in 20mg sodium nitrite tid for therapeutic use?

The current 20mg NaNO₂ tid therapeutic product is highly effective when given acutely in an unselected group of ICU patients with a high mortality risk, such as in a surgical or trauma ICU. Given this observation and our own experience of using the product over several years, we anticipate that this dosage is going to help improve patient survival. Data from a recent study could be important for patients being admitted to an ICU without a life-threatening disease or with such a disease that may be amenable to treatment with sodium nitrite.

Anonymous Patient Answer

How serious can frailty be?

Frailty is significantly associated to the occurrence of new disabling illness and death in community-dwelling older persons. Older persons with disabilities are especially vulnerable for adverse events. In conclusion, the use of the FFI is a simple and easy tool in the assessment of the health situation of older persons. Thus, the present study shows that the FFI is worthy of further validation. But, some of its dimensions must be improved as the measurement method.

Anonymous Patient Answer

Have there been other clinical trials involving 20mg sodium nitrite tid?

In summary, there have been many small clinical trials involving 20 mg tins of NO₂ applied directly to the patient. These trials, with the exception of two small, single-site ones, have found no treatment-related morbidity. This research has led to the conclusion at this time that there is not a large body of evidence to suggest that the 20 mg tins of nitric oxide can be safely administered to patients at home. Results from a recent clinical trial suggest that caution should be used when prescribing a treatment regimen around the NO₂ spray.

Anonymous Patient Answer
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