Table 5.
Mixed Models for Predicting Each Maternal Safety Parameter
| Safety parameter | Beta estimate | Beta standard error | p-Value |
|---|---|---|---|
| 1. Serum calcium | |||
| Treatment 400 IU | Reference | ||
| Treatment 6,400 IU | −0.00678 | 0.01093 | |
| Treatment | 0.9185 | ||
| Visit 4 | Reference | ||
| Visit 7 | −0.02656 | 0.007972 | |
| Visit | 0.0011 | ||
| Treatment by visit interaction 400 IU | Reference | ||
| Treatment by visit interaction 6,400 IU | 0.01563 | 0.01110 | |
| Treatment by visit interaction | 0.1604 | ||
| 2. Serum creatinine | |||
| Treatment 400 IU | Reference | ||
| Treatment 6,400 IU | −0.00048 | 0.001224 | |
| Treatment | 0.3464 | ||
| Visit 4 | Reference | ||
| Visit 7 | −0.00144 | 0.000844 | |
| Visit | 0.0009 | ||
| Treatment by visit interaction 400 IU | Reference | ||
| Treatment by visit interaction 6,400 IU | −0.00119 | 0.001171 | |
| Treatment by visit interaction | 0.3095 | ||
| 3. Urinary calcium/creatinine ratio | |||
| Treatment 400 IU | Reference | ||
| Treatment 6,400 IU | 0.03997 | 0.03242 | |
| Treatment | 0.1736 | ||
| Visit 4 | Reference | ||
| Visit 7 | 0.009965 | 0.02440 | |
| Visit | 0.5428 | ||
| Treatment by visit interaction 400 IU | Reference | ||
| Treatment by visit interaction 6,400 IU | 0.001259 | 0.03403 | |
| Treatment by visit interaction | 0.9705 | ||
| 4. Serum iPTH | |||
| Treatment 400 IU | Reference | ||
| Treatment 6,400 IU | −0.1752 | 0.2716 | |
| Treatment | 0.3240 | ||
| Visit 4 | Reference | ||
| Visit 7 | 0.4041 | 0.2249 | |
| Visit | 0.0349 | ||
| Treatment by visit interaction 400 IU | Reference | ||
| Treatment by visit interaction 6,400 IU | −0.1315 | 0.3103 | |
| Treatment by visit interaction | 0.6725 | ||
Adjusted for baseline value, baseline 25-hydroxy vitD concentration, 25-hydroxy vitD concentration at visit 4 and visit 7, race, and feeding category.