Table 2. Statistical comparison of study outcomes.
| Outcome | Period | p-value | |
|---|---|---|---|
| Protocol | SAM | ||
| Percentage Hb 10 – 12 g/dL* | 62.7 | 69.3 | 0.0631 |
| Percentage Hb < 9 g/dL | 4.1 | 7.6 | 0.1841 |
| Percentage Hb < 10 g/dL | 13.9 | 24.2 | 0.0061 |
| Percentage Hb > 12 g/dL | 23.4 | 6.5 | < 0.0011 |
| Hb (g/dL) | 11.2 ± 0.5 | 10.5 ± 0.6 | < 0.0012 |
| Intra-individual Hb variability (g/dL) | 1.1 [0.4, 2.4] | 0.8 [0.2, 1.8] | < 0.0011 |
| Inter-individual Hb variability (g/dL) | 1.2 [1.0, 1.5] | 1.0 [0.9, 1.2] | 0.0101 |
| Kt/V | 1.6 ± 0.2 | 1.5 ± 0.2 | 0.2772 |
| Serum albumin (g/dL) | 3.9 ± 0.3 | 3.9 ± 0.2 | 0.3052 |
| Transferrin saturation (%) | 30.8 ± 6.0 | 32.7 ± 8.6 | 0.1352 |
| Serum ferritin (ng/mL) | 845 [179, 1,759] | 1,071 [62, 3,319] | < 0.0011 |
| Serum calcium (g/dL) | 8.8 ± 0.6 | 8.9 ± 0.5 | 0.1982 |
| Serum phosphorus (mg/dL) | 5.8 ± 1.3 | 5.6 ± 1.4 | 0.6142 |
| PTH (pg/mL) | 398 [30, 2107] | 501 [52, 4,106] | 0.0121 |
| MCH (pg) | 30.2 ± 2.6 | 30.6 ± 2.6 | 0.3972 |
| MCHC (g/dL) | 32.2 ± 1.1 | 31.9 ± 0.9 | 0.2372 |
| MCV (fL) | 93.7 ± 6.8 | 95.7 ± 7.2 | 0.1352 |
| Weekly ESA dose (IU) | 7,800 [1,000, 58,000] | 3,000 [1,000, 35,000] | < 0.0011 |
| Weekly iron dose (mg) | 43 [0, 211] | 16 [0,102] | < 0.0011 |
| Percentage completed treatments | 90 | 91 | 0.5821 |
Normally distributed variables reported as mean ± standard deviation. Non-normally distributed variables reported as median [min, max]. Hb = hemoglobin; PTH = parathyroid hormone; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume. *Primary outcome; 1Wilcoxon signed rank test; 2Paired sample t-test.