FIA Acute Inflammation
NCT07931937, Not applicable, Not yet recruiting, University of Zurich
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | FIA Acute Inflammation | ClinicalTrials.gov |
| NCT number | NCT07931937 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Zurich | ClinicalTrials.gov |
| Conditions | Inflammation, Iron Absorption, Community-Acquired Pneumonia (CAP), Anemia of Acute Inflammation, Iron Metabolism Disorders | ClinicalTrials.gov |
| Interventions | ⁵⁷Fe-labelled ferrous sulphate, ⁵⁸Fe-citrate | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Within-Participant Change in Fractional Iron Absorption Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Serum Hepcidin Concentration Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Blood Hemoglobin Concentration Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Erythrocyte Incorporation of Intravenously Administered ⁵⁸Fe | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Hematocrit Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Serum Ferritin Concentration Between Acute Inflammation and Convalescence | 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. | Serum ferritin concentration is measured in micrograms per liter (µg/L). Acute-phase and convalescent values are compared within each participant. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Serum Iron Concentration Between Acute Inflammation and Convalescence | 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. | Serum iron concentration is measured in micromoles per liter (µmol/L). Acute-phase and convalescent values are compared within each participant. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Transferrin Saturation Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Total Iron-Binding Capacity Between Acute Inflammation and Convalescence | 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. | Total iron-binding capacity is measured in micromoles of iron per liter (µmol/L). Acute-phase and convalescent values are compared within each participant. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Soluble Transferrin Receptor Concentration Between Acute Inflammation and Convalescence | 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. | Soluble transferrin receptor concentration is measured in milligrams per liter (mg/L). Acute-phase and convalescent values are compared within each participant. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Erythroferrone Concentration Between Acute Inflammation and Convalescence | 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. | Erythroferrone concentration is measured in nanograms per milliliter (ng/mL). Acute-phase and convalescent values are compared within each participant. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in C-Reactive Protein Concentration Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Interleukin-6 Concentration Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Absolute Reticulocyte Count Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Secondary | Within-Participant Change in Reticulocyte Percentage Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Other | Within-Participant Change in Ferritin Subunit Composition Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Other | Within-Participant Change in Ferritin Iron Loading Between Acute Inflammation and Convalescence | 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. | 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. | ClinicalTrials.gov |
| Other | Incidence, Severity and Relatedness of Adverse Events and Serious Adverse Events | 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. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)