Clinical Study of Hydroxytyrosol (HT) in Mitochondrial Diseases
Mitochondrial Diseases
About this trial
This is an interventional treatment trial for Mitochondrial Diseases focused on measuring mitochondria, mitochondrial diseases, MD, mitochondrial dysfunction, mitochondrial respiratory chain, MRC, oxidative phosphorylation, OXPHOS, mitochondrial
Eligibility Criteria
Inclusion criteria
- Subject (aged 3-18 years) is confirmed to have pathogenic MD-associated nuclear DNA or mtDNA mutations.
- Subject is willing and able to comply with all requirements of the clinical trial.
- Subject is given enough time and opportunity to consider his/her participation and has signed his/her written consent.
Exclusion criteria
- Subject is participating or has participated within the last 2 months in any clinical trial involving hydroxytyrosol (HT) or hydroxytyrosol (HT) -associated phenols as dietary supplements.
- Subject has a medical condition which can be exacerbated by hydroxytyrosol (HT) or hydroxytyrosol (HT) -associated phenols.
- Subject has allergy to olive oil.
- Subject is pregnant.
Sites / Locations
- Hong Kong Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
hydroxytyrosol (HT) intake
hydroxytyrosol (HT) intake and withdraw
MD patients will receive hydroxytyrosol (HT) daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to continue on receiving hydroxytyrosol (HT) as their dietary supplements for another 6 months. Doses of hydroxytyrosol (HT) intake: (1) 3-10 years old, 10 mg/day; (2) 11-18 years old 30mg/day
MD patients will receive hydroxytyrosol (HT) daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to withdraw from receiving hydroxytyrosol (HT) as their dietary supplements for another 6 months. Doses of hydroxytyrosol (HT) intake: (1) 3-10 years old, 10 mg/day; (2) 11-18 years old 30mg/day