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

N

National University Health System (NUHS)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Parkinson Disease

Treatments

Dietary Supplement: coenzyme q10

Study type

Interventional

Funder types

Other

Identifiers

NCT01892176
DSRB/2010/00223

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

21+ months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Coenzyme Q10
Experimental group
Description:
400mg/day, 800mg/day, 1200/day and 2400mg/day
Treatment:
Dietary Supplement: coenzyme q10

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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