FIA Acute Inflammation (FIA-AI)
Fractional Iron Absorption in Acute Inflammation
The goal of this clinical trial is to learn how acute inflammation affects the body's ability to absorb iron in adults who are hospitalized with community-acquired pneumonia.
The main questions it aims to answer are:
- How does intestinal iron absorption change during acute inflammation compared with after recovery?
- How are changes in iron absorption related to markers of iron metabolism and inflammation, including hepcidin?
Participants will:
- Receive an oral dose of stable isotope-labelled ⁵⁷Fe-ferrous sulfate, followed one hour later by a small intravenous dose of stable isotope-labelled ⁵⁸Fe-citrate.
- Provide blood samples to measure iron absorption, iron status, and markers of inflammation.
- Repeat the study procedures after recovery from the acute illness to compare iron absorption during acute inflammation and convalescence.
- Attend follow-up visits over approximately 3-4 months.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Iron deficiency is common in patients with acute inflammatory diseases and contributes to impaired erythropoiesis and delayed recovery. During acute inflammation, increased hepcidin concentrations reduce intestinal iron absorption and alter systemic iron homeostasis by limiting iron export from enterocytes and macrophages. Although these mechanisms are well established, quantitative data on fractional iron absorption during acute inflammation and its recovery after resolution of the inflammatory response remain limited.
This prospective, single-centre, open-label, mechanistic interventional study is designed to quantify fractional iron absorption during acute inflammation and compare it with fractional iron absorption after recovery in the same participant. Participants hospitalized with community-acquired pneumonia and marked systemic inflammation (C-reactive protein >=100 mg/L) undergo the identical dual stable-isotope procedure twice: once during the acute phase, within 72 hours of hospitalization (Visit 1), and once during convalescence, 3 to 8 weeks after hospital discharge and only after C-reactive protein has fallen to <=10 mg/L (Visit 3).
At each of the two dosing visits, following a fast of at least 4 hours, participants receive a single oral dose of 10 mg elemental iron as stable isotope-labelled ⁵⁷Fe-ferrous sulphate, taken under supervision with 200 mL of water and a standardised test meal of white bread, butter and honey. Fasting continues for 4 hours after the oral dose. One hour after the oral dose, a reference dose of 100 µg total iron as stable isotope-labelled ⁵⁸Fe-citrate, diluted in 100 mL of 0.9% sodium chloride, is infused over 50 minutes by infusion pump through a peripheral venous catheter, with monitoring during and after the infusion. Both isotopes are non-radioactive and are given at tracer doses; the oral dose is approximately one tenth of a usual therapeutic daily iron dose and is not expected to alter iron status.
Fractional iron absorption is determined 14 to 21 days after each administration (Visits 2 and 4) from the erythrocyte incorporation of the oral ⁵⁷Fe tracer relative to the intravenous ⁵⁸Fe reference tracer, measured by inductively coupled plasma mass spectrometry. Baseline erythrocyte isotope ratios are measured before each dosing visit to correct for pre-existing isotopic enrichment.
Serial blood samples will be collected to assess iron metabolism and inflammatory activity, including serum iron, ferritin, transferrin saturation, total iron-binding capacity, soluble transferrin receptor, erythroferrone, hepcidin, C-reactive protein, interleukin-6, haemoglobin, haematocrit, reticulocyte measures and other laboratory parameters specified in the protocol. Measurements obtained during acute inflammation will be compared with those obtained during convalescence to evaluate the effects of resolution of inflammation on intestinal iron absorption and systemic iron metabolism.
In supporting exploratory analyses, fractional iron absorption (% of the oral dose absorbed) will be correlated separately with serum hepcidin (ng/mL), C-reactive protein (mg/L) and interleukin-6 (pg/mL). Each absorption value at Visits 2 and 4 will be paired with the biomarker concentrations measured at the same visit. Serum hepcidin will be measured by competitive enzyme-linked immunosorbent assay, with additional mass spectrometry if applicable. The University Hospital Zurich central laboratory will measure C-reactive protein and interleukin-6 using routine clinical assays. Each correlation will be reported as a unitless coefficient with a 95% confidence interval, accounting for repeated measurements within participants.
A total of 48 participants will be enrolled with the aim of obtaining 38 evaluable paired datasets. Fractional iron absorption will be analysed on the log10 scale, and the primary within-participant comparison will use a paired two-sided t-test at alpha 0.05, with results reported as geometric mean ratios and 95% confidence intervals. The findings will improve understanding of the relationship between acute inflammation, hepcidin, and iron absorption and provide mechanistic evidence to inform future studies and therapeutic strategies for the management of iron deficiency in patients with acute inflammatory diseases.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Raphael M Buzzi, MD PhD
- Telefonnummer: +41 44 255 24 30
- E-post: Raphael.buzzi@usz.ch
Studieorter
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Canton of Zurich
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Zurich, Canton of Zurich, Schweiz, 8091
- Klinik und Poliklinik für Innere Medizin, Universitätsspital Zürich
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Kontakt:
- Raphael M Buzzi, MD PhD
- Telefonnummer: +41 44 255 24 30
- E-post: Raphael.buzzi@usz.ch
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age ≥18 years.
- Body mass index (BMI) 18.5-30 kg/m².
- Hospitalization for acute infection with confirmed systemic inflammation, defined as C-reactive protein (CRP) ≥100 mg/L during the acute phase, with enrollment feasible within 72 hours of hospitalization.
- Confirmed community-acquired pneumonia (CAP), defined by a compatible clinical syndrome (e.g., fever, cough, dyspnea, sputum production, pleuritic chest pain) and/or a new infiltrate or opacity on chest imaging (X-ray or CT).
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Severe anemia (hemoglobin <70 g/L).
- Known pre-existing iron deficiency likely to dominate the mechanism under study.
- Oral iron supplementation within 14 days before enrollment.
- Intravenous iron administration within 3 months before enrollment.
- Significant blood loss (>500 mL) or blood transfusion within 3 months before enrollment or during an isotope assessment period.
- Known genetic disorders of iron deficiency or iron overload.
- Hemoglobinopathies with secondary iron overload.
- Myelodysplastic syndrome with secondary iron overload.
- Sepsis, septic shock, ICU admission, or clinical instability making study procedures unsafe.
- Severe malabsorption syndrome, gastric bypass, short bowel syndrome, exocrine pancreatic insufficiency, severe dysphagia, vomiting, or inability to tolerate oral study procedures.
- Decompensated liver disease (Child-Pugh class B or C).
- Chronic inflammatory disease requiring ongoing immunosuppressive therapy.
- Active replicating HIV infection, active hepatitis B or C, or active tuberculosis.
- Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73 m²) or treatment with erythropoiesis-stimulating agents.
- Active malignancy receiving systemic therapy.
- Severe chronic heart failure (e.g., left ventricular ejection fraction <25%).
- Known hypersensitivity to iron preparations or study excipients.
- Pregnancy, planned pregnancy, or breastfeeding.
- Participation in another interventional clinical trial within 30 days before enrollment.
- Inability to understand or comply with study procedures, including impaired decision-making capacity, acute delirium, major psychiatric disorder affecting informed consent, or a language barrier without an interpreter.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Experimental cohort
Each participant undergoes the identical dual stable-isotope procedure twice: once during the acute inflammatory phase (Visit 1) and once during convalescence (Visit 3). At each dosing visit an oral dose of ⁵⁷Fe-labelled ferrous sulphate is followed one hour later by a small intravenous ⁵⁸Fe-citrate reference dose. Fractional iron absorption is determined 14-21 days after each administration from erythrocyte incorporation of both stable isotopes, giving a within-participant comparison of absorption during acute inflammation and after recovery. |
Single oral dose of 10 mg elemental iron as stable isotope-labelled ⁵⁷Fe-ferrous sulfate, administered under supervision with 200 mL water and a standardised test meal (white bread, butter, honey) after a fast of at least 4 hours; fasting continues for 4 hours after dosing. Administered twice per participant: once during the acute inflammatory phase (Visit 1, within 72 hours of hospitalization, CRP >=100 mg/L) and once during convalescence (Visit 3, 3-8 weeks after hospital discharge, CRP <=10 mg/L). The oral tracer serves as the test dose for quantification of fractional intestinal iron absorption. Single intravenous reference dose of 100 µg total iron as stable isotope-labelled ⁵⁸Fe-citrate, diluted in 100 mL 0.9% sodium chloride and infused over 50 minutes by infusion pump through a peripheral venous catheter, starting 1 hour after the oral ⁵⁷Fe dose, with monitoring during and after the infusion. Administered twice per participant, at Visit 1 (acute inflammatory phase) and Visit 3 (convalescent phase). Because the intravenous tracer bypasses the intestine, it serves as the reference tracer for calculating fractional iron absorption from erythrocyte incorporation of the oral relative to the intravenous isotope. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Within-Participant Change in Fractional Iron Absorption Between Acute Inflammation and Convalescence
Tidsram: Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
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Fractional iron absorption is the percentage of the oral iron dose absorbed. It is calculated as 100 times the fraction of the oral ⁵⁷Fe dose incorporated into erythrocytes divided by the fraction of the intravenous ⁵⁸Fe reference dose incorporated into erythrocytes. Erythrocyte isotope ratios are measured by inductively coupled plasma mass spectrometry. The paired comparison uses log-transformed absorption values and is reported as the convalescent-to-acute geometric mean ratio with a 95% confidence interval. |
Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Within-Participant Change in Serum Hepcidin Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Serum hepcidin concentration (ng/mL) is measured by competitive enzyme-linked immunosorbent assay, with additional mass spectrometry if applicable. Acute-phase and convalescent concentrations are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Blood Hemoglobin Concentration Between Acute Inflammation and Convalescence
Tidsram: Change from Visit 1 (within 72 hours of hospital admission) to Visit 3 (scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L). Additional descriptive measurements are taken 14-21 days after each of these visits.
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Blood hemoglobin concentration (g/L) is measured by routine laboratory hematology. The outcome is the concentration at Visit 3 minus the concentration at Visit 1 (g/L). Values at all four visits are also summarized descriptively. |
Change from Visit 1 (within 72 hours of hospital admission) to Visit 3 (scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L). Additional descriptive measurements are taken 14-21 days after each of these visits.
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Erythrocyte Incorporation of Intravenously Administered ⁵⁸Fe
Tidsram: Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
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The percentage of the intravenous ⁵⁸Fe dose incorporated into circulating erythrocytes is determined from blood isotope measurements by inductively coupled plasma mass spectrometry. The percentage after acute-phase dosing is compared with the percentage after convalescent-phase dosing within the same participant. |
Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
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Within-Participant Change in Hematocrit Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Hematocrit is the percentage of whole blood volume occupied by erythrocytes. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Serum Ferritin Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Serum ferritin concentration is measured in micrograms per liter (µg/L). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Serum Iron Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Serum iron concentration is measured in micromoles per liter (µmol/L). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Transferrin Saturation Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Transferrin saturation is the percentage of total iron-binding capacity occupied by iron. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Total Iron-Binding Capacity Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Total iron-binding capacity is measured in micromoles of iron per liter (µmol/L). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Soluble Transferrin Receptor Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Soluble transferrin receptor concentration is measured in milligrams per liter (mg/L). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Erythroferrone Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Erythroferrone concentration is measured in nanograms per milliliter (ng/mL). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in C-Reactive Protein Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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C-reactive protein concentration is measured in milligrams per liter (mg/L) by the University Hospital Zurich central laboratory. Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Interleukin-6 Concentration Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Interleukin-6 concentration is measured in picograms per milliliter (pg/mL) by the University Hospital Zurich central laboratory. Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Absolute Reticulocyte Count Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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The absolute reticulocyte count is measured in billions of reticulocytes per liter of whole blood (10⁹/L). Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Reticulocyte Percentage Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Reticulocytes are reported as a percentage of the total red blood cell count. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Within-Participant Change in Ferritin Subunit Composition Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Ferritin Subunit ratio in coded blood samples using mass spectrometry. The result is expressed unitless as a ratio. Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Within-Participant Change in Ferritin Iron Loading Between Acute Inflammation and Convalescence
Tidsram: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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We will measure iron associated with ferritin in coded blood samples using mass spectrometry. The result is expressed in ng iron per ferritin-subunit. Acute-phase and convalescent values are compared within each participant. |
Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
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Incidence, Severity and Relatedness of Adverse Events and Serious Adverse Events
Tidsram: From first isotope administration (Visit 1) through the final study visit (Visit 4, Day 14-21 after convalescent-phase dosing); up to approximately 20 weeks per participant. Ongoing events are followed until resolution or stabilisation.
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Number of participants with at least one adverse event or serious adverse event, summarised by severity (mild, moderate, severe) and by relationship to the study intervention (definitely, probably, possibly, unlikely, not related). Events of particular interest are collected by active enquiry at every visit: venipuncture-related events (haematoma, local pain, infection), intravenous administration events (extravasation, phlebitis, infusion reaction), and gastrointestinal symptoms following the oral isotope dose. Clinically relevant abnormalities in routine laboratory parameters and vital signs are also recorded. |
From first isotope administration (Visit 1) through the final study visit (Visit 4, Day 14-21 after convalescent-phase dosing); up to approximately 20 weeks per participant. Ongoing events are followed until resolution or stabilisation.
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Florence Vallelian, Prof, Klinik und Poliklinik für Innere Medizin, Universitätsspital Zürich
- Huvudutredare: Raphael M Buzzi, MD PhD, Klinik und Poliklinik für Innere Medizin, Universitätsspital Zürich
- Studiestol: Dominik J Schaer, Prof, Klinik und Poliklinik für Innere Medizin, Universitätsspital Zürich
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Metaboliska sjukdomar
- Luftvägsinfektioner
- Infektioner
- Luftvägssjukdomar
- Lunginflammation
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Samhällsförvärvade infektioner
- Inflammation
- Störningar i järnmetabolism
- Samhällsförvärvad lunginflammation
- ferrous citrate
Andra studie-ID-nummer
- 26_1015_FIA-AI
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The study protocol and statistical analysis plan (SAP) will be published to ensure transparency of the study design and pre-specified analyses.
Along with publication of the primary study results, anonymised individual participant data underlying the published analyses will be shared. The shared dataset will include all participant-level data required to reproduce the published findings, including clinical data, laboratory measurements, stable iron isotope measurements, derived variables, analytic code, metadata, and a data dictionary. These materials will be deposited in Zenodo and assigned a persistent DOI.
Tidsram för IPD-delning
Anonymised individual participant data and supporting documentation will become available at the time of publication of the primary study results, and no later than 12 months after that publication. Once deposited, the data, study protocol, statistical analysis plan, analytic code, metadata and data dictionary will remain publicly available indefinitely through Zenodo under a persistent DOI, with no end date.
Kriterier för IPD Sharing Access
The anonymised individual participant dataset, study protocol, statistical analysis plan, analytic code, metadata and data dictionary will be publicly available to anyone without restriction through Zenodo, via a persistent DOI. No data sharing agreement or request procedure applies. Before deposition the dataset is anonymised: direct identifiers are removed, calendar dates are replaced by intervals relative to the first study visit, free-text fields are removed or recoded, and rare or potentially distinguishing values are aggregated or top-coded, so that re-identification is not reasonably possible. Anonymisation is documented and approved by the Principal Investigator and the responsible statistician prior to release. All materials are prepared in accordance with the applicable ethical approvals, participant consent, institutional policies and Swiss data protection law.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
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