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

Primary Purpose

Patients With Grade II Ankle Sprain

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Grade II Ankle Sprain focused on measuring Xanthine oxidase, Magnetic resonance, Oxidative stress, Inflammation

Eligibility Criteria

20 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Valencia
  • Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Muscle mass loss
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
Measure xanthine oxidase activity in plasma

Secondary Outcome Measures

size of the leg muscles in a group of immobilized subjects.
Checks the loss of muscle mass size with Magnetic Resonance before and after treatment.
oxidative stress parameters
Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration.

Full Information

First Posted
November 12, 2013
Last Updated
September 7, 2016
Sponsor
Instituto de Investigacion Sanitaria La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT01987570
Brief Title
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
Official Title
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Grade II Ankle Sprain
Keywords
Xanthine oxidase, Magnetic resonance, Oxidative stress, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
1H-pirazolo (3,4-d)pirimidina-4-ol, Zyloric
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Muscle mass loss
Description
Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.
Time Frame
Day 0 and day 15
Title
The role of xanthine oxidase in the loss of muscle mass
Description
Measure xanthine oxidase activity in plasma
Time Frame
Day 0 and day 15
Secondary Outcome Measure Information:
Title
size of the leg muscles in a group of immobilized subjects.
Description
Checks the loss of muscle mass size with Magnetic Resonance before and after treatment.
Time Frame
Day 0 and day 15
Title
oxidative stress parameters
Description
Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration.
Time Frame
Day 0 and day 15

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSÉ VIÑA, MD PhD (HON)
Organizational Affiliation
University of Valencia
Official's Role
Study Director
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

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

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