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

NCT ID: NCT01987570

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Patients With Grade II Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Allopurinol

Intervention Type: DRUG

Placebo

One tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Allopurinol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

1H-pirazolo (3,4-d)pirimidina-4-ol; Zyloric

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JOSÉ VIÑA, MD PhD (HON)

Role: STUDY_DIRECTOR

University of Valencia

Locations

University of Valencia

Valencia, Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

2011-003541-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALMU_2011

Identifier Type: -

Identifier Source: org_study_id