Status:
COMPLETED
Nicotinamide Riboside on Mitochondrial Function in Li-Fraumeni Syndrome
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cancer
Skin Fibroblasts
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Nicotinamide riboside (NR) is a vitamin B3 dietary supplement. It may help improve muscle function, that may in turn may improve a person s exercise capacity. Researchers want to study ho...
Detailed Description
We have previously reported that inherited mutations of TP53, which causes the premature cancer disorder Li-Fraumeni syndrome (LFS), can promote mitochondrial function both in patients and mouse model...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03789175
Start Date
March 25 2019
End Date
November 1 2019
Last Update
December 8 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892