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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coenzyme Q10

400mg/day, 800mg/day, 1200/day and 2400mg/day

Group Type EXPERIMENTAL

coenzyme q10

Intervention Type DIETARY_SUPPLEMENT

400mg/day, 800mg/day, 1200/day and 2400mg/day

Interventions

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coenzyme q10

400mg/day, 800mg/day, 1200/day and 2400mg/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No