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

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ClinicalTrials.gov Identifier: NCT01892176
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
Medicine, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: coenzyme q10 Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coenzyme Q10
400mg/day, 800mg/day, 1200/day and 2400mg/day
Dietary Supplement: coenzyme q10
400mg/day, 800mg/day, 1200/day and 2400mg/day




Primary Outcome Measures :
  1. Biomarkers of oxidative damage [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Total Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892176


Locations
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Singapore
National University Health System
Singapore, Singapore, 119228
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Raymond Seet, MBBS National University Health System

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Responsible Party: Medicine, Associate Professor, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01892176     History of Changes
Other Study ID Numbers: DSRB/2010/00223
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013
Keywords provided by Medicine, National University Hospital, Singapore:
coenzyme Q10, Parkinson disease, oxidative damage
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Coenzyme Q10
Ubiquinone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs