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This study examines the effect of Nicotinamide Riboside (NR) supplementation on mitochondrial (cell energy production) function in people with Li-Fraumeni syndrome, an inherited cancer predisposition caused by a TP53 gene mutation. People aged 18 and older with a genetically confirmed TP53 mutation and Li-Fraumeni syndrome who had fatigue symptoms were able to take part. The study was carried out in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* INCLUSION CRITERIA: * At least 18-years of age and able to give informed consent * Have delayed phosphocreatine (PCr) recovery time constant \>45 sec by 31P-magnetic resonance spectroscopy (MRS) testing and a history of fatigue symptoms * Ability to undergo study procedures, including scheduled visits, blood draws and skeletal muscle exercise Nuclear Magnetic Resonance (NMR) * Have Li-Fraumeni syndrome and confirmed TP53 mutation by genetic testing * Committed to using reliable contraception which may include abstinence during study participation * Female participants of child-bearing ability and potential willing to commit to reliable contraception while participating in the study EXCLUSION CRITERIA: * Current systemic treatment for cancer * Unable to perform required study visits or procedures * Magnetic resonance imaging (MRI) incompatible hardware * Pregnant or breastfeeding women * History of intolerance to NR precursor compounds, including niacin or nicotinamide