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New treatment option for Fatigue
Official title Effects of Nutrition on Post Stroke Fatigue
ClinicalTrials.gov ID: NCT05728229
What this study is testing
What is Supplement with SiderAl® Med?
Supplement with SiderAl® Med is an investigational medicine, given as an once-daily, being studied as a potential treatment for fatigue.
Also referred to as SiderAl® Med.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fatigue, which is commonly defined as a feeling of tiredness during or after usual activities, or a feeling of insufficient energy to initiate these activities, is one of the most common secondary conditions among patients presenting with stroke. Post Stroke Fatigue (PSF) is a multidimensional motor-perceptual, emotional, and cognitive experience characterized by a feeling of early exhaustion with tiredness, lack of energy, and difficulty making efforts, which develops during physical or mental activities, and usually does not improve with rest.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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...
- Ability to walk independently or with little assistance;
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.