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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892176
• Other study ID #: DSRB/2010/00223
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 30, 2013
• Last updated: July 8, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Months and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• coenzyme q10
400mg/day, 800mg/day, 1200/day and 2400mg/day

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of oxidative damage		10 weeks	No
Secondary	Total Unified Parkinson's Disease Rating Scale (UPDRS)		10 weeks	No