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Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.

This study has been completed.
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe Identifier:
First received: November 12, 2013
Last updated: September 7, 2016
Last verified: July 2015

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.

Condition Intervention Phase
Patients With Grade II Ankle Sprain
Drug: Allopurinol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.

Resource links provided by NLM:

Further study details as provided by Instituto de Investigacion Sanitaria La Fe:

Primary Outcome Measures:
  • Muscle mass loss [ Time Frame: Day 0 and day 15 ]
    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 ]
    Measure xanthine oxidase activity in plasma

Secondary Outcome Measures:
  • size of the leg muscles in a group of immobilized subjects. [ Time Frame: Day 0 and day 15 ]
    Checks the loss of muscle mass size with Magnetic Resonance before and after treatment.

  • oxidative stress parameters [ Time Frame: Day 0 and day 15 ]
    Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration.

Enrollment: 53
Study Start Date: April 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol
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.
Drug: Allopurinol
Other Names:
  • 1H-pirazolo (3,4-d)pirimidina-4-ol
  • Zyloric
Placebo Comparator: Placebo
One tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days.
Drug: Placebo


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with grade II sprain.
  • Boys
  • Age 20-40 years.
  • Patient without regular medication.
  • All patients must provide written informed consent specific to this study complete.

Exclusion Criteria:

  • Liver and gastrointestinal disease.
  • Untreated hypothyroidism.
  • Alcohol and / or drug addiction.
  • Vitamin supplements.
  • Eating Disorders.
  • Drugs that decrease the concentration of lipids.
  • Antihypertensive drugs.
  • Athletes who exercise intensely.
  • Mental disorders, depression or anxiety intensive. These conditions make the patient unable to understand the nature or the scope and possible consequences of the study.
  • Patients presenting an infectious process and / or inflammatory before collecting the sample.
  • Patients may not follow the protocol because of its lack of cooperation, to their inability to return to subsequent visits and there is little chance of completing the study procedures.
  • Hypersensitivity to allopurinol
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Please refer to this study by its identifier: NCT01987570

University of Valencia
Valencia, Spain, 46010
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Study Director: JOSÉ VIÑA, MD PhD (HON) University of Valencia
  More Information

Responsible Party: Instituto de Investigacion Sanitaria La Fe Identifier: NCT01987570     History of Changes
Other Study ID Numbers: ALMU_2011
2011-003541-17 ( EudraCT Number )
Study First Received: November 12, 2013
Last Updated: September 7, 2016

Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Xanthine oxidase
Magnetic resonance
Oxidative stress

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs processed this record on May 24, 2017