20mg sodium nitrite tid for Frailty
This study is evaluating whether nitrite therapy may have positive impacts for individuals with mitochondrial dysfunction.
See full descriptionAbout the trial for Frailty
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.
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.