Temporal changes in laboratory parameters
| Parameter | FCM (n=24) | Placebo (n=24) | Mean treatment effect of FCM (95% CI) | P value | ||||
| Baseline | Week 1 | Week 8 | Baseline | Week 1 | Week 8 | |||
| Iron parameters | ||||||||
| Iron, µmol/L | 16.5±7.3 | 28.8±9.5 | 17.3±5.4 | 16.8±6.1 | 16.5±6.7 | 15.3±5.3 | 4.6 (1.6 to 7.6) | 0.003 |
| Ferritin, µg/L | 96.4±62.5 | 1149.5±282.2 | 395.2±161.4 | 97.7±78.1 | 91.4±70.6 | 95.8±79.5 | 318.8 (265.7 to 371.8) | <0.001 |
| Transferrin, g/L | 2.53±0.32 | 2.06±0.25 | 2.08±0.22 | 2.53±0.31 | 2.48±0.34 | 2.49±0.35 | −0.47 (−0.53 to −0.40) | <0.001 |
| Transferrin saturation, % | 31.3±15.1 | 64.9±24.3 | 38.2±12.4 | 31.4±15.7 | 31.3±17.1 | 29.0±13.6 | 13.3 (7.8 to 18.7) | <0.001 |
| Soluble transferrin receptor, nmol/L | 16.2±4.4 | 13.0±3.5 | 14.3±3.4 | 17.1±5.0 | 16.8±5.2 | 16.8±5.7 | −3.2 (−3.9 to −2.6) | <0.001 |
| Hepcidin, ng/mL | 21.8±12.2 | 106.8±33.9 | 58.5±22.5 | 21.8±18.9 | 18.7±17.3 | 26.7±25.6 | 39.4 (29.7 to 49.0) | <0.001 |
| Haematological parameters | ||||||||
| Haemoglobin, g/L | 145.4±12.1* | 141.3±11.8* | 144.5±12.3* | 144.1±14.4* | 140.3±12.9* | 141.3±14.5* | 0.4 (−3.2 to 4.0) | 0.82 |
| Mean corpuscular volume, fL | 90.6±5.3* | 91.3±5.2* | 92.8±5.2* | 92.3±3.6* | 92.6±3.4* | 92.2±3.7* | 0.8 (0.3 to 1.3) | 0.003 |
| Mean cell haemoglobin, pg | 30.2±2.2* | 30.4±2.1* | 30.7±1.9* | 30.7±1.2* | 30.4±1.1* | 30.3±1.1* | 0.7 (0.4 to 1.0) | <0.001 |
| Inflammatory parameters | ||||||||
| C reactive protein, mg/dL | 6.7±14.6 | 8.0±10.2 | 5.5±6.3 | 6.5±8.2 | 6.0±8.7 | 5.8±6.7 | 0.4 (−4.4 to 5.2) | 0.86 |
| Interleukin-6, pg/mL† | 7.8±8.8 (13) | 4.8±1.7 (11) | 4.6±1.6 (11) | 8.2±6.8 (8) | 7.5±4.2 (14) | 7.5±5.5 (6) | −3.4 (−7.6 to 0.8) | 0.11 |
| Serum phosphate, mmol/L | 0.98±0.17 | 0.52±0.14 | 0.83±0.24 | 0.97±0.13 | 0.97±0.15 | 0.97±0.16 | −0.46 (−0.51 to −0.40) | <0.001 |
All data are reported as mean±SD.
Statistical analysis was performed by linear mixed effects modelling.
P values and mean treatment effect are given for the fixed effect of ‘status post FCM infusion’.
*Descriptive data (mean±SD) are reported for participants with a valid measurement at each time point (n=23); cases with partially missing data were excluded. Participants with missing data were still included in the linear mixed effects model.
†Interleukin-6: values in parentheses indicate the number of data points with values below the assay’s detection threshold of 3.13 pg/mL. These values were not included in the descriptive statistics or the linear mixed effects model.
FCM, ferric carboxymaltose.