Table 2.
Primary Analysis – Key Lab Values
| ERC, (n = 174) | AVD, (n = 55) | NVD, (n = 147) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lab Value | Pre | Post | ∆ | MeanFU | MedFU | Pre | Post | ∆ | MeanFU | MedFU | Pre | Post | ∆ | MeanFU | MedFU |
|
25D, ng/mL* Mean (SE) |
20.3a (0.7) |
44.0 (1.7) |
23.7aa,bb,cc (1.6) |
24.6 | 19.9 |
23.5 (1.0) |
29.0 (1.2) |
5.5cc (1.3) |
21.3 | 18.1 |
18.8aa (0.6) |
28.5 (1.6) |
9.7cc (1.5) |
21.1 | 17.6 |
|
PTH, pg/mL* Mean (SE) |
181.4bb (7.4) |
147.4 (7.1) |
−34.1bb,cc (6.6) |
23.4 | 18.8 |
156.9 (9.7) |
149.9 (11.1) |
−7.0 (9.8) |
21.6 | 18.1 |
134.8 (6.8) |
144.4 (9.5) |
9.6 (6.0) |
20.7 | 17.4 |
|
Ca, mg/dL Mean (SE) |
9.2b (0.1) |
9.3 (0.1) |
0.1 (0.1) |
27.8 | 22.2 |
9.1 (0.1) |
9.3 (0.1) |
0.2cc (0.1) |
21.4 | 18.1 |
9.3 (0.1) |
9.3 (0.1) |
0.0 (0.1) |
20.4 | 16.1 |
|
P, mg/dL Mean (SE) |
3.8 (0.1) |
3.9 (0.1) |
0.1 (0.1) |
28.8 | 22.1 |
3.8 (0.2) |
3.9 (0.2) |
0.1 (0.1) |
24.5 | 18.6 |
3.7 (0.1) |
3.8 (0.1) |
0.1 (0.1) |
20.5 | 15.9 |
|
ALP, IU/L Mean (SE) |
96.9 (3.6) | 95.3 (3.8) | −2.1 (1.9) | 28.4 | 21.6 | 82.1 (7.4) | 79.8 (6.5) | −2.3 (2.7) | 21.3 | 18.6 | 97.0 (3.4) | 99.8 (4.0) | 2.7 (2.4) | 18.3 | 14.7 |
|
eGFR Mean (SE) |
31.1b (1.1) |
28.0 (0.9) |
−3.1cc (0.7) |
28.1 | 22.2 |
30.3b (1.4) |
28.7 (1.6) |
−1.6c (0.6) |
21.4 | 18.1 |
35.7 (1.0) |
34.5 (1.0) |
−1.2c (0.6) |
20.0 | 16.0 |
aSignificantly different from AVD, one-way ANOVA with Tukey’s multiple comparision test, p < 0.05
aaSignificantly different from AVD, one-way ANOVA with Tukey’s multiple comparision test, p < 0.001
bSignificantly different from NVD, one-way ANOVA with Tukey’s multiple comparision test, p < 0.05
bbSignificantly different from NVD, one-way ANOVA with Tukey’s multiple comparision test, p < 0.001
cSignificantly different from baseline, p < 0.05
ccSignificantly different from baseline, p < 0.001
ERC Extended-Release Calcifediol; AVD Active Vitamin D; NVD Nutritional Vitamin D; 25D, 25-hydroxyvitamin D; PTH parathyroid hormone; Ca serum calcium; P serum phosphorus; ALP alkaline phosphatase; IU International Units; eGFR estimated glomerular filtration rate; Pre pretreatment value; Post post-treatment value; Δ, Change from Pre to Post-treatment; MeanFU Mean Follow-up time (weeks); MedianFU, Median Follow-up time (weeks)