Nutrition's impact on fatigue after stroke
Effetti Della Nutrizione Sulla Fatica Post Stroke
This study is testing if a nutritional supplement can help stroke survivors feel less tired and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05728229 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of nutritional supplementation on post-stroke fatigue, a common condition affecting stroke survivors. Twenty-four patients will be randomly assigned to either receive a nutritional supplement alongside their ongoing drug therapy or continue with standard rehabilitation without the supplement. The aim is to assess whether the addition of SiderAL® Med can improve energy levels and overall well-being in these patients. The study will take place at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.
Who should consider this trial
Good fit: Ideal candidates are adults aged 5 years and older who have experienced an ischemic or hemorrhagic stroke within the last 1 to 6 months and can follow simple instructions.
Not a fit: Patients with certain medical conditions, such as those on high doses of Vitamin D or with specific metabolic disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to alleviating fatigue in stroke survivors, enhancing their quality of life.
How similar studies have performed: While the approach of using nutritional supplements for fatigue is promising, it remains relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 5 years; * Patients with ischemic or haemorrhagic stroke outcomes documented through neuroimaging techniques (magnetic resonance or computed tomography); * Latency from the acute event between 1 and 6 months; * Cognitive skills that allow you to carry out simple orders and understand the physiotherapist's instructions \[assessed through the Token Test (score ≥ 26.5)\]; * Ability to walk independently or with little assistance; * Ability to understand and sign informed consent. Exclusion Criteria: * Vitamin D intake greater than 3000 IU/day; * Therapy with Vitamin K antagonists; * Conditions causing excess electrolytes in the blood; * Diagnosis of metabolic mineral storage disorders (eg, hemochromatosis, Wilson); * Dialysis patients; * Systemic, neurological, cardiac pathologies that make walking risky or cause motor deficits; * Oncological pathologies; * Problems of an orthopedic or postural nature; * Presence of plantar ulcers; * Partial or total amputation of segments of the foot; * Inability to provide informed consent.
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Giovannini, MD, phD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Silvia Giovannini, MD, phD
- Email: silvia.giovannini@policlinicogemelli.it
- Phone: +390630154382
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.