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

NCT01987570 | Completed Phase 3 DMC

• 2 other identifiers: ALMU_20112011-003541-17
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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

Keywords

Xanthine oxidase; Magnetic resonance; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Muscle mass loss

  Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.

  Day 0 and day 15

• The role of xanthine oxidase in the loss of muscle mass

  Measure xanthine oxidase activity in plasma

  Day 0 and day 15

Secondary Outcomes (2)

• size of the leg muscles in a group of immobilized subjects.

  Day 0 and day 15

• oxidative stress parameters

  Day 0 and day 15

Study Arms (2)

Allopurinol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Allopurinol DRUG

Also known as: 1H-pirazolo (3,4-d)pirimidina-4-ol, Zyloric

Allopurinol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (2)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Inflammation

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• JOSÉ VIÑA, MD PhD (HON)

  University of Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: April 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2015-07

Locations

ES (2)