Creatine supplementation to aid recovery after ischemic stroke
Effect of Supplementation With Creatine on the Early Recovery of Ischemic Stroke: A Randomized Clinical Trial
This study is testing if taking creatine can help people recover better and regain strength after having an ischemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundació d'investigació Sanitària de les Illes Balears Government |
| Locations | 1 site (Palma de Mallorca, Balearic Islands) |
| Trial ID | NCT06576466 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of creatine supplementation in enhancing physical and functional recovery in patients who have recently suffered an ischemic stroke. The study employs a randomized, double-blind design, comparing the effects of creatine monohydrate to a placebo. It aims to address the significant loss of functionality and muscle mass that stroke survivors experience, focusing on improving mobility and overall recovery outcomes. Participants will be recruited within a specific time frame post-stroke, ensuring timely intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have recently been diagnosed with ischemic stroke and require motor rehabilitation.
Not a fit: Patients with severe pre-existing disabilities or those unable to walk without assistance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for ischemic stroke patients.
How similar studies have performed: While the use of creatine has been widely studied in athletic performance, its application in post-stroke recovery is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 80 years * Recent diagnosis of ischemic stroke (from 24 hours to 5 days) . * Neurological deficit due to the stroke that affects mobility (paresis and/or ataxia) and requires motor rehabilitation. * Ability to understand and sign the informed consent form, or failing that, have sufficient support to carry out the correct follow-up of the study. Exclusion Criteria: * Moderate-severe disability prior to stroke, defined by an mRS\>2. * Unstable or severe clinical situation that prevents active rehabilitation. * Neurological deficit due to stroke that prevents walking without help from another person. The use of support with a cane, crutch or walker is permitted. * Moderate or severe dysphagia that makes therapeutic adherence difficult. * Use of creatine supplements in the last 3 months, or use of anabolic products in the last 3 months. * Severe kidney disease (GFR \<30ml/min/1.73 m2). * Musculoskeletal pathology that prevents assessment of muscle strength. For example: fractures, severe osteoarthritis, ligament tears or tendinopathies. * History of allergic reactions to creatine. * Pregnancy or breastfeeding. * Simultaneous participation in another clinical trial.
Where this trial is running
Palma de Mallorca, Balearic Islands
- IdISBa — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
Study contacts
- Principal investigator: Raquel Delgado Mederos, PhD — Fundació d'investigació Sanitària de les Illes Balears
- Study coordinator: Raquel Delgado Mederos, PhD
- Email: raquel.delgado@ssib.es
- Phone: 0034971205234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.