Table 2:
Baseline and 1-year follow-up lab measurements, among placebo- and vitamin D-treated participants a
| Cohort with baseline and 1-year measurements | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline in blood cohort (n=15805) | Baseline in 1YR cohort (n=1660) | 1-year (n=1660) | Change from BL to 1-year (n=1660) | Percent Change b (n=1660) | ||||||||
| Treatment | med(IQR) | mean (SD) | med(IQR) | mean (SD) | med(IQR) | mean (SD) | med(IQR)1 | mean (CI) 2 | p-value3 | mean (CI)2 | p-value3 | |
| 25(OH)D total, LC-MS/MS, | Placebo | 31.0 (13.0) | 30.8 (10.0) | 29.2 (12.0) | 29.7 (9.8) | 29.2 (12.0) | 29.0 (9.6) | −0.9 (6.8)*** | −0.7** (−1.2, −0.2) | <.0001 | −2.6** (−4.3, −0.8) | <.0001 |
| [ng/mL] | Vitamin D | 31.0 (12.9) | 30.9 (10.0) | 30.0 (14.5) | 29.8 (10.4) | 40.3 (12.0) | 41.7 (10.0) | 11.1 (11.0)*** | 11.9*** (11.3, 12.5) | 45.2*** (42.1, 48.4) | ||
| 25(OH)D3, LC-MS/MS | Placebo | 30.0 (12.0) | 30.2 (10.2) | 29.2 (12.8) | 29.0 (9.9) | 28.3 (12.0) | 28.2 (9.7) | −0.9 (6.8)*** | −0.9*** (−1.3, −0.4) | <.0001 | −3.6*** (−5.3, −1.9) | <.0001 |
| [ng/mL] | Vitamin D | 30.0 (13.0) | 30.4 (10.2) | 29.2 (13.7) | 29.3 (10.6) | 40.3 (11.9) | 41.4 (10.1) | 11.1 (10.3)*** | 12.1*** (11.5, 12.7) | 47.4*** (44.0, 50.9) | ||
| 25(OH)D total, CMIA | Placebo | 31.1 (10.3) | 31.8 (8.5) | 30.5 (11.4) | 31.4 (8.3) | 30.2 (10.1) | 30.7 (8.0) | −0.8 (5.1)*** | −0.7*** (−1.0, −0.3) | <.0001 | −2.0** (−3.1, −0.8) | <.0001 |
| [ng/mL] | Vitamin D | 31.1 (10.2) | 31.9 (8.7) | 30.8 (10.8) | 31.6 (9.9) | 41.4 (12.3) | 43.1 (10.6) | 10.8 (9.7)*** | 11.6 *** (11.0, 12.1) | 38.5 *** (36.4, 40.7) | ||
| Calcium [mg/dL] | Placebo | 9.4 (0.5) | 9.4 (0.4) | 9.5 (0.7) | 9.6 (0.6) | 9.5 (0.6) | 9.5 (0.6) | 0 (0.6) | 0 (−0.05,0.03) | 0.790 | −0.1 (−0.5, 0.3) | 0.836 |
| Vitamin D | 9.4 (0.5) | 9.4 (0.4) | 9.5 (0.7) | 9.6 (0.5) | 9.5 (0.7) | 9.6 (0.5) | 0 (0.6) | 0 (−0.04,0.04) | 0 (−0.4, 0.4) | |||
| iPTH [pg/ml] | Placebo | 35.0 (21.0) | 39.3 (18.6) | 40.7 (27.8) | 44.7 (23.6) | 40.7 (25.1) | 44.9 (24.5) | 1.0 (21.3) | 0.3 (−1.2, 1.7) | <.0001 | 0.1 (−4.5, 4.9) | 0.004 |
| Vitamin D | 35.0 (20.0) | 39.2 (19.2) | 38.6 (25.7) | 43.8 (25.6) | 34.5 (21.6) | 39.1 (22.6) | −3.1 (17.5)*** | −4.8*** (−6.1, −3.4) | −8.6*** (−12.5, −4.6) | |||
a
Abbreviations: SD=standard deviation: IQR=interquartile range; CI=95% confidence interval; 25(OH)D=25-hydroxivitamin D; LC-MS/MS= liquid chromatography-tandem mass spectrometry; CMIA=chemiluminescent microparticle immunoassay.
b
Percent change reported as geometric mean, calculated based on log-transformed data
1
Nonparametric Wilcoxon signed-rank test for comparison between baseline and 1-year median
2
Paired t-test for comparison between baseline and 1-year mean
3
Two sample t-test for comparison of mean change between treatment groups
*
p<0.05,
**
p<0.01,
***
p<0.001