Nutrition's impact on fatigue after stroke
Official title: Effetti Della Nutrizione Sulla Fatica Post Stroke
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05728229 · Data updated 2026-11-12
This study is testing if a nutritional supplement can help stroke survivors feel less tired and improve their overall well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | November 7, 2022 |
| Main results expected | September 29, 2024 |
| Study ends | December 2025 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT05728229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
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Post-stroke fatigue and related clinical factors
We will try to find how common fatigue is and which health and personal factors are linked to it in adults at least three months after their first stroke.
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
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Magnetic stimulation treatment for fatigue after stroke
This study is testing whether a type of magnetic treatment can help stroke survivors feel less tired and improve their overall well-being.
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AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.