Effect of coenzyme Q10 in fibromyalgia patients: study of symptoms and gene expression

ISRCTN ISRCTN21164124
DOI https://doi.org/10.1186/ISRCTN21164124
Secondary identifying numbers N/A
Submission date
07/08/2012
Registration date
12/09/2012
Last edited
28/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Fibromyalgia (FM) is a chronic, long-term condition that causes pain all over the body. It affects approximately 2% of the general population. People with the condition may suffer from a generalised increased sensitivity to pain (hyperalgesia) and a wide range of other symptoms such as allodynia (pain caused by stimuli that would not normally be painful), fatigue (extreme tiredness), joint stiffness and migraines. The treatments currently available only work to some extent. It is not known what causes FM but levels of Coenzyme Q10 (CoQ10), a fat-soluble nutrient that we produce naturally in our bodies, have been found to be low in FM sufferers. The purposes of this study are to assess the effect of CoQ10 on the symptoms of FM patients and to look at the conditions’ inflammatory gene expression profile.

Who can participate?
Patients between 18 and 65 who have been diagnosed with FM

What does the study involve?
Patients are randomly placed into one of two groups. One group will be given CoQ10, and the other group a placebo. We hope to find a novel therapeutic approach for FM

What are the possible benefits and risks of participating?
Preliminary data have shown some improvements in the clinical symptoms for FM sufferers. There are no known adverse effects from the oral CoQ10 treatment.

Where is the study run from?
University of Sevilla, Spain

When is study starting and how long is it expected to run for?
September 2012 to June 2013

Who is funding the study?
Andalusian Federation of Fibromyalgia and Chronic Fatigue Syndrome, Spain

Who is the main contact?
Professor Pedro Bullón
pbullon@us.es

Contact information

Prof Pedro Bullón
Scientific

University of Sevilla
Department of Periodontology
Dental School
C/Avicena s/n
Sevilla
41009
Spain

Email pbullon@us.es

Study information

Study designRandomised placebo controlled double blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA pilot randomized placebo-controlled trial of coenzyme Q10 in fibromyalgia patients
Study objectivesCoenzyme Q10 (CoQ10) is an essential electron carrier in the mitochondrial respiratory chain and a strong antioxidant. Low CoQ10 levels has been detected in patients with Fibromyalgia (FM). The purpose of the present work was to assess the effect of CoQ10 on symptoms of patients with FM and evaluate the inflammatory gene expression profile in blood mononuclear cells from FM patients.
Ethics approval(s)University of Sevilla Ethics Committee, 7 July 2012
Health condition(s) or problem(s) studiedFibromyalgia
InterventionThe participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Intervention group:
300 mg ubiquinone capsule (oral) (Pharmanord, Vejle, Denmark) three times daily for 3 months

Control group:
Placebo (lactose powder) in similar capsules twice daily for 3 months

Total duration of follow-up: 90 days
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Coenzyme Q10
Primary outcome measure1. Coenzyme Q10 levels by High-performance liquid chromatography (HPLC)
2. Oxidative stress by spectrophotometic methods and flow cytometer
3. Inflamation parameters by Enzyme-linked immunosorbent (ELISA) assays
4. Clinical symptoms using diagnostic criteria ACR 1990, Fibromyalgia Impact Questionnaire (FIQ), Visual Analogue Scale (VAS) of pain, Beck Depression Inventory (BDI) (depression), and Pittsburgh test to determinate the quality of dream.
Secondary outcome measuresGene expression by Real time polymerase chain reaction (PCR)
Overall study start date15/09/2012
Completion date01/06/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Male and female patients between 18 and 65 years old
2. Has FM according to official diagnostic criteria for FM established in 1990 by the American College of Rheumatology (ACR)
3. Duration of the illness of ten years or less
Key exclusion criteria1. History of renal failure (creatinine equal to or superior than 1.8 mL/dL), coronary disease in the last six months, angina, congestive heart disease, diabetes mellitus type one and two
2. Any life-threatening chronic disease (i.e., cancer disease, inflammatory bowel disease and active immune disorders)
3. Rheumatic disease (i.e., inflammatory arthritis, polymyositis, polymyalgia rheumatica)
4. Osteomalacia and osteoporosis
5. Metabolic and endocrine disease (i.e., hypothyroidism and hyperthyroidism, hyperparathyroidism, adrenal insufficiency, metabolic myopathy)
6. Infectious diseases (i.e., Epstein-Barr virus disease, brucellosis)
7. Rheumatic disease of soft tissue and myofascial pain syndrome
8. Parkinson’s disease
9. Women to become pregnant or nursing
10. Patients who are enrolled in other clinical trial or patients who participated in other clinical trial in the last 30 days
11. Any psychological or psychiatric disease to compromise the understanding of the instructions giving by the investigator
12. Any subject to be unable to follow a good complementation of the treatment
13. Any patient who denies to give the informed consent to participate in this trial
Date of first enrolment15/09/2012
Date of final enrolment01/06/2013

Locations

Countries of recruitment

  • Spain

Study participating centre

University of Sevilla
Sevilla
41009
Spain

Sponsor information

Andalusian Federation of Fibromyalgia and Chronic Fatigue Syndrome (Spain)
Charity

[Federación Andaluza de Fibromialgia y Fatiga crónica]
C/ Virog local 10 y 11
Jerez de la Frontera - Cádiz
11406
Spain

Website http://www.confederacionfmfc.org/

Funders

Funder type

Charity

Andalusian Federation of Fibromyalgia and Chronic Fatigue Syndrome (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/10/2013 Yes No