NCT01892176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

June 30, 2013

Last Update Submit

July 8, 2013

Conditions

Parkinson Disease

Keywords

coenzyme Q10, Parkinson disease, oxidative damage

Outcome Measures

Primary Outcomes (1)

  • Biomarkers of oxidative damage

    10 weeks

Secondary Outcomes (1)

  • Total Unified Parkinson's Disease Rating Scale (UPDRS)

    10 weeks

Study Arms (1)

Coenzyme Q10

EXPERIMENTAL

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

Dietary Supplement: coenzyme q10

Interventions

coenzyme q10DIETARY_SUPPLEMENT

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

Coenzyme Q10

Eligibility Criteria

Age21 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • idiopathic Parkinson disease
  • age \>21 years
  • able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Health System

Singapore, Singapore, 119228, Singapore

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Raymond Seet, MBBS

    National University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 30, 2013

First Posted

July 4, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

SG(1)