Page 74 - Haematologica May 2020

N.U. Stoffel et al.
administration day) were defined as fixed effects, partici- pants as random effects (intercept) using a variance com- ponent structure matrix. Spearman correlation was applied. Incidences of side effects were compared using χ2 test. P-values<0.05 were considered statistically signifi- cant.
Results
We began recruiting on October 10, 2017, and during October and November 2017, we enrolled 19 women in the study. Three women were included in the study based on their Hb concentration before blood donation; 16 women were included in the study based on their Hb concentration after blood donation. We completed the study on January 8, 2018. Three women left the study after completing the first
supplementation period: two after the 100 mg dosing (one because of gastrointestinal side effects, one because of trav- els away from the study site) and one after the 200 mg dos- ing (because of travels away from the study site). The data from these three women from the first supplementation period were included in the final analysis.
Baseline characteristics
Table 1 shows the subject characteristics at baseline (day 1) and at day 22, by randomization group. At base- line, four subjects were borderline anemic with a baseline Hb between 12.0-12.5 g/dL (two in each group) and three subjects, who received 100 mg iron first, had a mild upper respiratory tract infection and had an elevated baseline c- reactive protein (CRP); all of these subjects were included in the analysis. There were no significant within-group or
Figure 1. Study design. SHep: serum hepcidin; RBC: red blood cells.
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