Back to resultsEffects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
coenzyme q10
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring coenzyme Q10, Parkinson disease, oxidative damage
Eligibility Criteria
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
Sites / Locations
- National University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coenzyme Q10
Arm Description
400mg/day, 800mg/day, 1200/day and 2400mg/day
Outcomes
Primary Outcome Measures
Biomarkers of oxidative damage
Secondary Outcome Measures
Total Unified Parkinson's Disease Rating Scale (UPDRS)
Full Information
NCT ID
NCT01892176
First Posted
June 30, 2013
Last Updated
July 8, 2013
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01892176
Brief Title
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Official Title
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
coenzyme Q10, Parkinson disease, oxidative damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coenzyme Q10
Arm Type
Experimental
Arm Description
400mg/day, 800mg/day, 1200/day and 2400mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
coenzyme q10
Intervention Description
400mg/day, 800mg/day, 1200/day and 2400mg/day
Primary Outcome Measure Information:
Title
Biomarkers of oxidative damage
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Total Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Seet, MBBS
Organizational Affiliation
National University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Health System
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
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