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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01987570
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Brief Summary:

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 or disease Intervention/treatment Phase
Patients With Grade II Ankle Sprain Drug: Allopurinol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : April 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Muscle mass loss [ Time Frame: Day 0 and day 15 ]
    Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.

  2. 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 :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01987570

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University of Valencia
Valencia, Spain, 46010
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
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Study Director: JOSÉ VIÑA, MD PhD (HON) University of Valencia
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Responsible Party: Instituto de Investigacion Sanitaria La Fe Identifier: NCT01987570    
Other Study ID Numbers: ALMU_2011
2011-003541-17 ( EudraCT Number )
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: July 2015
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Xanthine oxidase
Magnetic resonance
Oxidative stress
Additional relevant MeSH terms:
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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