Patients With Grade II Ankle Sprain Clinical Trial
Official title:
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
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.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari i Politècnic La Fe | Valencia | |
| Spain | University of Valencia | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Investigacion Sanitaria La Fe |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Muscle mass loss | Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment. | Day 0 and day 15 | No |
| Primary | The role of xanthine oxidase in the loss of muscle mass | Measure xanthine oxidase activity in plasma | Day 0 and day 15 | Yes |
| Secondary | 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. | Day 0 and day 15 | No |
| Secondary | oxidative stress parameters | Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration. | Day 0 and day 15 | Yes |