Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: coenzyme q10

• Registration Number: NCT01892176
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.

Detailed Description

Subjects with idiopathic PD will be recruited to a 10-week dose escalation study. Each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. Information on safety and fasting blood/urine samples will be collected. Primary endpoint is plasma F2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. Serum phospholipase A2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-06-30
• Study First Submitted QC: 2013-06-30
• Status Verified: 2013-07
• Study First Posted: 2013-07-04
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• idiopathic Parkinson disease
• age >21 years
• able to provide written informed consent

Exclusion Criteria

• diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking
• major psychiatric disorder or drug and/or alcohol abuse/dependence
• regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10	coenzyme q10	400mg/day, 800mg/day, 1200/day and 2400mg/day

Primary Outcome Measures

Name	Time	Method
Biomarkers of oxidative damage	10 weeks

Secondary Outcome Measures

Name	Time	Method
Total Unified Parkinson's Disease Rating Scale (UPDRS)	10 weeks

Trial Locations

Locations (1)

National University Health System; 🇸🇬 Singapore, Singapore