Effects of Nutrition on Post Stroke Fatigue
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 4, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a nutritional supplement called SiderAL® Med on fatigue experienced by patients who have had a stroke. Fatigue after a stroke can be a challenging condition, making it hard for individuals to feel energized or motivated to engage in everyday activities. The trial aims to see if taking this supplement, which contains essential vitamins and minerals, can help improve both physical and mental tiredness in these patients.
To participate in this trial, individuals must be at least 5 years old and have experienced either an ischemic (caused by a blockage) or hemorrhagic (caused by bleeding) stroke within the last 1 to 6 months. They should also be able to walk independently or with minimal help and understand simple instructions. Participants will be monitored to see if the nutritional supplement helps reduce their fatigue and improves their overall energy levels. It’s important to note that certain health conditions and treatments may exclude someone from participating, so potential volunteers should discuss their eligibility with their healthcare provider.
Gender
ALL
Eligibility 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.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, Rm, Italy
Patients applied
Trial Officials
Silvia Giovannini, MD, phD
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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