Status:
COMPLETED
Nicotinamide Riboside and Mitochondrial Biogenesis
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Cambridge
Medical Research Council Mitochondrial Biology Unit
Conditions:
Mitochondrial Diseases
Mitochondrial Myopathies
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Mitochondria are important parts of the cell that are responsible for producing energy. The amount of energy they produce depends on how much energy the body needs to function and this energy producti...
Detailed Description
Mitochondria are the primary source of energy within the cell, in the form of adenosine triphosphate (ATP). Mitochondrial ATP production is tightly regulated according to the energy requirements of th...
Eligibility Criteria
Inclusion
- Clinical and genetic diagnosis of:
- Progressive external ophthalmoplegia (PEO), caused by a single deletion of mitochondrial DNA
- or
- Mitochondrial disease caused by the m.3243A\>G or A\>T mutation in mitochondrial DNA
- Age 18-70 years
- Women of child-bearing age only if they are not pregnant or breast feeding at the inclusion into the study and agree not to become pregnant during the study. Female participants will undergo a pregnancy test before study commencement.
- Signed informed patient consent
Exclusion
- Clinically significant liver disease (e.g., cirrhosis or a history of hepatitis)
- Presence of significant other neurological disorders (such as multiple sclerosis, Parkinson's disease) or major co-morbidities (such as definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders)
- Females who are at risk of pregnancy (i.e., not using regular contraception), who are pregnant, lactating or planning pregnancy
- Females taking the combined oral contraceptive pill (as oestrogens can induce mitochondrial biogenesis and interfere with study results)
- For MRI - medical contraindication e.g., pacemaker, deep brain stimulator, aneurysm clip or significant claustrophobia
- For biopsy - varicose veins overlying biopsy site, clinically significant lower limb oedema, active lower limb infection, use of anticoagulants or antiplatelet agents that cannot be discontinued, known bleeding diathesis
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03432871
Start Date
December 8 2017
End Date
December 31 2022
Last Update
July 20 2023
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB20QQ