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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Instituto de Investigacion Sanitaria La Fe
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier:
NCT01987570
First received: November 12, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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
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.

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 ] [ 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987570

Locations
Spain
Hospital Universitari i Politècnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Enrique Viosca    34961246611    viosca_enr@gva.es   
Principal Investigator: Enrique Viosca         
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: José Viña, MD Phd (HON)    963864646 ext 64650    jose.vina@uv.es   
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
Study Director: JOSÉ VIÑA, MD PhD (HON) University of Valencia
  More Information

No publications provided

Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01987570     History of Changes
Other Study ID Numbers: ALMU_2011, 2011-003541-17
Study First Received: November 12, 2013
Last Updated: November 27, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014