Table 4.
Hematologic and inflammatory status for subjects with SCD-SS and Controls by dose group at each visita
| SCD | Controls | |||||
|---|---|---|---|---|---|---|
| Baseline | 6-weeks | 12-weeks | Baseline | 6-weeks | 12-weeks | |
| N | 19 | 19 | 16 | 22 | 19 | 18 |
| 4,000 | 10 | 10 | 8 | 10 | 9 | 9 |
| 7,000 | 9 | 9 | 8 | 12 | 10 | 9 |
| HgbF (%) | 12.4 ± 5.8b | 12.7 ± 5.9 | 14.0 ± 6.2*2 | |||
| 4,000 IU | 9.9 ± 5.3 | 10.5 ± 5.5 | 11.5 ± 5.43 | |||
| 7,000 IU | 15.1 ± 5.4 | 15.1 ± 5.7 | 16.1 ± 6.3¥ | |||
| Hematocrit (%) | 25.9 ± 3.1 | 25.9 ± 3.0 | 25.7 ± 3.4 | 39.8 ± 3.1 | 40.4 ± 3.3 | 40.0 ± 4.2 |
| 4,000 IU | 24.9 ± 3.3 | 25.4 ± 3.2 | 24.4 ±3.6 | 40.5 ± 3.7 | 40.5 ± 3.5 | 40.9 ± 5.5 |
| 7,000 IU | 27.0 ± 2.6 | 26.4 ± 2.8 | 26.9 ± 3.0 | 39.3 ± 2.6 | 40.3 ± 3.2 | 40.0 ± 1.9 |
| Hemoglobin (g/dl) | 8.4 ± 1.0 | 8.4 ± 1.0 | 8.2 ± 1.1 | 13.0 ± 1.1 | 13.2 ± 1.0 | 13.0 ± 1.4 |
| 4,000 IU | 8.1 ± 1.2 | 8.2 ± 1.0 | 8.0 ± 1.0 | 13.1 ± 1.2 | 13.2 ± 1.1 | 13.2 ± 1.8 |
| 7,000 IU | 8.7 ± 0.8 | 8.6 ± 0.9 | 8.6 ± 1.0 | 13.0 ± 1.1 | 13.2 ± 1.1 | 12.7 ± 0.7 |
| MCH | 30.1 ± 3.4 | 30.1 ± 3.3 | 30.1 ± 3.4 | 27.2 ± 2.1 | 27.1 ± 2.1 | 26.8 ± 2.0 |
| 4,000 IU | 29.6 ± 4.1 | 29.6 ± 3.9 | 30.0 ± 4.5 | 26.3 ± 2.5 | 26.5 ± 2.5 | 26.3 ± 2.4 |
| 7,000 IU | 30.6 ± 2.7 | 30.7 ± 2.5 | 30.2 ± 2.3 | 27.9 ± 1.4 | 27.7 ± 1.6 | 27.3 ± 1.3 |
| MCHC (g/dl) | 32.4 ± 1.0 | 32.4 ± 0.7 | 32.2 ± 1.0 | 32.7 ± 1.1 | 32.7 ± 0.9 | 32.5 ± 1.0 |
| 4,000 IU | 32.4 ± 1.3 | 32.2 ± 0.9 | 32.5 ± 1.1 | 32.3 ± 1.2 | 32.7 ± 0.8 | 32.3 ± 0.8 |
| 7,000 IU | 32.4 ± 0.7 | 32.6 ± 0.5 | 32.0 ± 0.8 | 33.0 ± 1.0 | 32.9 ± 1.0 | 32.7 ± 1.2 |
| MCV (fL) | 92.7 ± 9.2 | 93.0 ± 9.5 | 93.3 ± 9.8 | 83.0 ± 5.5 | 82.7 ± 5.9 | 82.6 ± 5.4 |
| 4,000 IU | 91.0 ± 10.1 | 92.0 ± 11.5 | 92.0 ± 11.6 | 81.4 ± 6.4 | 81.0 ± 6.5 | 81.5 ± 6.6 |
| 7,000 IU | 94.5 ± 8.1 | 94.2 ± 7.3 | 94.6 ± 8.1 | 84.3 ± 4.5 | 84.3 ± 5.1 | 83.7 ± 4.1 |
| WBC (× 103/µL) | 9.5 ± 2.3 | 9.7 ± 2.0 | 9.5 ± 1.8 | 5.3 ± 1.5 | 5.4 ± 1.7 | 5.7 ± 1.7** |
| 4,000 IU | 9.6 ± 2.8 | 9.8 ± 1.4 | 9.4 ± 1.8 | 5.5 ± 1.6 | 5.8 ± 1.7 | 6.4 ± 1.8** |
| 7,000 IU | 9.5 ± 1.7 | 9.5 ± 2.7 | 9.6 ± 1.9 | 5.1 ± 1.4 | 5.1 ± 1.8 | 5.0 ± 1.1 |
| RBC (× 106/µL) | 2.8 ± 0.5 | 2.8 ± 0.5 | 2.8 ± 0.5 | 4.8 ± 0.5 | 4.9 ± 0.4 | 4.8 ± 0.5 |
| 4,000 IU | 2.8 ± 0.7 | 2.8 ± 0.7 | 2.7 ± 0.8 | 5.0 ± 0.5 | 5.0 ± 0.5 | 5.0 ± 0.5 |
| 7,000 IU | 2.9 ± 0.2 | 2.8 ± 0.3 | 2.8 ± 0.2 | 4.7 ± 0.5 | 4.8 ± 0.4 | 4.7 ± 0.4 |
| HS-CRP (mg/L) | 3.0 ± 2.6 | 2.0 ± 1.7* | 1.1 ± 1.5 | 1.2 ± 1.9 | ||
| 4,000 IU | 2.0 ± 2.01 | 1.3 ± 1.0 | 0.7 ± 0.7 | 1.0 ± 1.2 | ||
| 7,000 IU | 4.0 ± 2.7 | 2.8 ± 2.1* | 1.5 ± 1.9 | 1.4 ± 2.5 | ||
| Platelets (× 103/µL) | 522 ± 158 | 522 ± 143 | 457 ± 143* | 304 ± 64 | 316 ± 73 | 311 ± 72 |
| 4,000 IU | 599 ± 174 | 586 ± 173 | 482 ± 188* | 295 ± 61 | 322 ± 80 | 329 ± 87 |
| 7,000 IU | 436 ± 80† | 451 ± 39‡ | 433± 87 | 310 ± 68 | 311 ± 71 | 294 ± 54 |
SCD-SS, type SS sickle cell disease; HgbF, fetal hemoglobin; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; MCV, mean corpuscular volume; WBC, white blood cells; RBC, red blood cells; HS-CRP, high-sensitivity C-reactive protein. Longitudinal-mixed-effects (LME) analyses were used to examine change over time and whether patterns of change were different between the two groups and two vit D doses. These analyses were made using the intention-to-treat model where all subjects are included regardless of adherence to the study protocol. For these LME analyses which controlled for baseline value, the subject or dose group was treated as a random effect and measurement and time as fixed effects.
P<0.05, 12-weeks vs. baseline in SCD,
trend P=0.08,
P<0.05, 12-weeks vs. baseline in Controls,
P<0.05, 7,000 vs. 4,000 at baseline,
P<0.05, 7,000 vs. 4,000 at 6-weeks.
Mean ± SD (all such values)
n=9
n=15
n=7