Table 2.
Groups | Overall Effects | Between Group Comparisons | |||||||
---|---|---|---|---|---|---|---|---|---|
Control | CF-FeFum | CF-FePP | Time p = | Treatment p = | Time by Treatment Interaction p = | Control vs. CF-FeFum p = | Control vs. CF-FePP p = | CF-FeFum vs. CF-FePP p = | |
Participants N = | |||||||||
Baseline | 125 | 126 | 127 | ||||||
6 months | 104 | 111 | 116 | ||||||
9 months | 76 | 81 | 87 | ||||||
Hb concentration (g/dL, mean, ±SD) | |||||||||
Baseline | 9.8 ± 1.3 | 9.9 ± 1.2 | 9.6 ± 1.2 | <0.001 | 0.948 | 0.141 | |||
6 months | 9.9 ± 1.3 | 9.9 ± 1.3 | 10.0 ± 1.1 | 0.761 | 0.479 | 0.306 | |||
9 months | 10.3 ± 1.3 * | 10.4 ± 1.2 * | 10.5 ± 1.2 ** | 0.871 | 0.226 | 0.161 | |||
Anemia (Hb < 11 g/dL) | |||||||||
Baseline | 81.6% | 80.2% | 86.6% | <0.001 | 0.475 | 0.237 | |||
6 months | 79.8% | 77.5% | 81.9% | 0.216 | 0.953 | 0.746 | |||
9 months | 71.1% | 70.4% | 65.5%* | 0.083 | 0.036 a | 0.069 a | |||
PF (μg/L, median, interquartile range 25th 75th) | |||||||||
Baseline | 37.7 (18.3–72.4) | 36.2 (21.6–66.0) | 53.0 (28.4–115.7) | <0.001 | 0.068 | 0.458 | |||
6 months | 60.7 (35.1–114.0) *** | 102.4 (48.3–159.5) *** | 69.1 (41.8–139.7) *** | <0.003 a | 0.048 a | 0.214 | |||
9 months | 49.6 (26.2–96.0) ** | 66.5 (45.4–117.4) *** | 62.6 (41.1–107.2) *** | 0.072 a | 0.150 | 0.426 | |||
ID (PF < 30 µg/L) | |||||||||
Baseline | 37.4% | 40.0% | 26.7% | <0.001 | 0.004 | 0.068 | |||
6 months | 19.2% * | 5.4% *** | 8.6% *** | <0.003 a | 0.006 a | 0.368 | |||
9 months | 29.3% | 3.7% *** | 10.3% *** | <0.003 a | 0.003 a | 0.171 | |||
IDA (PF < 30 μg/L and Hb < 11 g/dL) | |||||||||
Baseline | 33.3% | 32.8% | 23.6% | <0.001 | 0.003 | 0.028 | |||
6 months | 15.4% ** | 3.6% *** | 4.3% *** | 0.036 a | 0.096 a | 0.689 | |||
9 months | 18.7% | 1.2% *** | 3.4% *** | 0.027 a | 0.018 a | 0.388 | |||
ID and inflammation (PF < 30 μg/L and inflammation: CRP > 5 mg/L and/or AGP > 1 g/L) | |||||||||
Baseline | 21.1% | 24.0% | 14.2% | <0.001 | 0.001 | 0.080 | |||
6 months | 11.5% * | 4.5% *** | 4.3% *** | 0.099 a | 0.096 a | 0.900 | |||
9 months | 14.7% | 2.5% ** | 2.3% ** | 0.033 a | 0.021 a | 0.919 | |||
Anemia, ID, and inflammation (Hb < 11 g/dL and PF < 30 µg/L and inflammation: CRP > 5 mg/L and/or AGP > 1 g/L) | |||||||||
Baseline | 18.7% | 20.8% | 13.4% | <0.001 | 0.003 | 0.040 | |||
6 months | 10.6% | 2.7% ** | 3.4% *** | 0.048 a | 0.090 a | 0.513 | |||
9 months | 12.0% | 1.2% ** | 1.1% ** | 0.063 a | 0.048 a | 0.944 |
a Changes between baseline to six months and baseline to nine months were compared between groups with random effect models. For the between group comparison at follow-up, time (0, 6, and 9 months) was considered as categorical variable, For group differences with significant p-values (<0.05) a Bonferroni correction was applied. Abbreviations: AGP, α-1-acid-glycoprotein; CRP, C-reactive protein; Hb, hemoglobin; PF, plasma ferritin; SD, standard deviation. * p < 0.05, ** p < 0.01, *** p < 0.001 significant difference within the same group from baseline to six months or baseline to nine months.