Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An enzyme involved in the production of free radicals in various experimental models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial is to determine the effect of allopurinol administration on the prevention of muscle mass loss in immobilized subjects.
This is a prospective, randomized study in which fifty young male subjects (aged between 25 and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization the patients will be assigned randomly to one of two experimental groups, one treated with allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization period, which will last fifteen days. This medication will be delivered to the patients when they agree to participate in the clinical trial. They will be immobilized by posterior knee splint, preventing use of that leg.
We will determine muscle mass loss by performing two magnetic resonances of both legs before and after the immobilization period. We will also take two blood samples (before and after immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls, and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin), as well as vitamin D levels.
Patients With Grade II Ankle Sprain
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.|
- Muscle mass loss [ Time Frame: Day 0 and day 15 ] [ Designated as safety issue: No ]Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.
- The role of xanthine oxidase in the loss of muscle mass [ Time Frame: Day 0 and day 15 ] [ Designated as safety issue: Yes ]Measure xanthine oxidase activity in plasma
- size of the leg muscles in a group of immobilized subjects. [ Time Frame: Day 0 and day 15 ] [ Designated as safety issue: No ]Checks the loss of muscle mass size with Magnetic Resonance before and after treatment.
- oxidative stress parameters [ Time Frame: Day 0 and day 15 ] [ Designated as safety issue: Yes ]Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
One tablet of allopurinol is administrated orally at a dose of 300 mg/24 hours, during the time that the patient remains immobilized for 15 days.
Placebo Comparator: Placebo
One tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01987570
|Hospital Universitari i Politècnic La Fe||Recruiting|
|Valencia, Spain, 46026|
|Contact: Enrique Viosca 34961246611 firstname.lastname@example.org|
|Principal Investigator: Enrique Viosca|
|University of Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: José Viña, MD Phd (HON) 963864646 ext 64650 email@example.com|
|Study Director:||JOSÉ VIÑA, MD PhD (HON)||University of Valencia|