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The use of vitamin K2 in Parkinson’s Disease patients with mitochondrial dysfunction: A theranostic, proof-of-concept, placebo- controlled trial in a parallel group design

The use of vitamin K2 in Parkinson’s Disease patients with mitochondrial dysfunction: A theranostic, proof-of-concept, placebo- controlled trial in a parallel group design - PD-K2

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00019932
Enrollment
130
Registered
2019-12-19
Start date
2020-02-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20.00

Interventions

Group 1: treatment with 1 mg of vitamin K2 (MK-7) on a daily basis for seven days Group 2: placebo

Sponsors

Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age =18 years; written informed consent; PD diagnosis based on MDS criteria (if applicable); stable PD medication (if applicable)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
n. a.

Countries

Germany

Contacts

Public ContactNorbert Brüggemann

Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus LübeckInstitut für Neurogenetik,Universität zu Lübeck

norbert.brueggemann@neuro.uni-luebeck.de0451-5000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 16, 2026