Status:
COMPLETED
Ketones & Mitochondrial Heteroplasmy
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
MELAS Syndrome
Mitochondrial Diseases
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA at position 3243 (A\>G). S...
Detailed Description
The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known pathogenic mutation in their mtDNA at position 324...
Eligibility Criteria
Inclusion
- Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
- Subject is willing and able to comply with all trial requirements.
- Subject harbors the 3243 A\>G mtDNA mutation at a level detectable in blood.
- Female subjects of child-bearing potential must not be pregnant. Female subjects of child-bearing potential (not surgically sterile or 2 years post-menopausal) must also agree to use appropriate contraceptive methods (abstinence, oral, injectable, implantable, or barrier) for the duration of the trial.
- Subject must not have diabetes mellitus.
Exclusion
- Subject is currently participating or has participated within the last 2 months in any clinical trial involving treatment of mitochondrial disorders with MCT supplementation or induction of ketosis.
- Subject has a medical condition that could reasonably be exacerbated by ketone supplementation (including diabetes mellitus).
- Subject is unable to give reasonable informed consent/assent.
- Subject is a pregnant or nursing female.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01252979
Start Date
December 1 2010
End Date
December 1 2011
Last Update
February 6 2012
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030