G93.3
Conditions
Interventions
Group 1: In this prospective observational study, patients with ME/CFS undergoing clinically indicated iron supplementation will be assessed. Clinical symptoms, fatigue severity, autonomic symptoms, a
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Post-COVID syndrome (PCS) at least 6 months after COVID-19 or another viral infection, and: Diagnosis of ME/CFS according to the Canadian Consensus Criteria (CCC), including exertion intolerance and symptom exacerbation lasting at least 14 hours (ME/CFS), or Clinically relevant impairment due to the disease, defined as a Bell score of =30 Iron deficiency with a clinical indication for iron supplementation, defined as: ferritin <50 µg/L, or ferritin 100–299 µg/L and transferrin saturation (TSAT) <20% Written informed consent provided by the patient
Exclusion criteria
Exclusion criteria: Unwillingness to allow storage of pseudonymized health data within the study Pregnancy Other conditions that may confound or preclude a clear diagnosis of PCS (e.g., cardiac disease, pulmonary disease, severe depression, malignancy) Organ involvement in the context of PCS (e.g., defined autoimmune diseases, interstitial lung disease (ILD), myocarditis) Acute infection (e.g., COVID-19, HIV, hepatitis) Severe ME/CFS with complete bed confinement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SF-36 Physical Function (PF) score (range 0–100) from baseline to at least 4 weeks after clinically indicated iron supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in handgrip strength Change in vascular function, including endothelial function (EndoPAT) and orthostatic intolerance (heart rate and blood pressure in sitting and standing positions) Change in autonomic nervous system function (ANS analysis) Change in Short Physical Performance Battery (SPPB) score Change in Chalder Fatigue Scale score (range 0–33) Change in PEM criteria (assessment of frequency, severity, and duration; range 0–46) Change in Bell score (range 0–100) Change in health-related quality of life measured by EQ-5D | — |
Countries
Germany
Contacts
Public ContactNadja Jauert
Institut für Immunologie, Charité-Universitätsmedizin Berlin
Outcome results
None listed