The use of vitamin K2 inParkinson’s Disease patients withmitochondrial dysfunction:A theranostic, proof-of-concept, placebo- controlled trial in a parallel group desig
- Conditions
- G20.00
- Registration Number
- DRKS00019932
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein, Campus Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 130
Age =18 years; written informed consent; PD diagnosis based on MDS criteria (if applicable); stable PD medication (if applicable)
comorbidities that might impair informed consent;
MRI contraindications or structural brain diseases (e. g. stroke);
atypical or secondary parkinsonism;
unstable PD medication (if applicable);
known allergy/intolerance to vitamin K2;
treatment with vitamin K2 or vitamin K-antagonist one month prior to the start of this trial;
chronic GI malabsorption (e.g. celiac disease, short bowel syndrome);
ongoing malignancy;
abuse of alcohol or other euphoric drug;
women who are pregnant or breast-feeding;
total/subtotal parathyroidectomy;
treatment with recombined parathormone;
treatment with bisphosphonates (or other anti-osteoporotic drugs);
treatment with statins
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Magnetic resonance spectroscopic measurement of adenosine triphosphate and phosphocreatine (normalized for inorganic phosphate) pre- and postinterventionally after one-week treatment with vitamin K2 (1 mg/d for a total of seven days) compared with placebo<br>
- Secondary Outcome Measures
Name Time Method n. a.