Table 2.

The primary and secondary outcomes by treatment type

VariablePlaceboCalcitriolCalcifediolCalcitriol versus PlaceboCalcifediol versus PlaceboCalcifediol versus Calcitriol
Pulse wave velocity,  m/sn=30n=28n=29
 Unadjusted baseline, mean (SD)10.6 (3.6)12.2 (3.6)12.4 (4.4)
 Unadjusted 6 mo, mean (SD)11.7 (3.5)12.4 (3.5)11.3 (3.9)
 Unadjusted change (95% CI) at 6 moa1.1 (0.1 to 2.2)0.2 (0.9 to 1.4)−1.1 (2.2 to 0.1)−0.8 (2.8 to 1.1)−2.1 (4.1 to 0.2)−1.3 (−3.2 to 0.7)
P valuea0.550.030.26
 Adjusted change (95% CI) at 6 mob0.7 (0.3 to 1.7)0.4 (0.6 to 1.4)−0.8 (1.8 to 0.2)−0.3 (2.0 to 1.5)−1.5 (3.2 to 0.3)−1.2 (2.9 to 0.5)
P valueb0.930.110.23
Systolic BP, mmHgn=35n=34n=33
 Unadjusted baseline, mean (SD)138.8 (16.6)135.2 (13.0)140.2 (21.3)
 Unadjusted 6 mo, mean (SD)139.3 (10.8)135.7 (13.0)144.1 (23.6)
 Unadjusted change (95% CI) at 6 moa0.5 (5.0 to 6.0)0.4 (5.1 to 6.0)4.0 (1.7 to 9.6)−0.1 (9.4 to 9.3)3.4 (6.0 to 12.9)3.5 (6.0 to 13.0)
P valuea0.990.660.65
 Adjusted change (95% CI) at 6 mob0.9 (3.9 to 5.6)−0.9 (5.7 to 3.9)5.0 (0.1 to 9.9)−1.8 (9.9 to 6.3)4.1 (4.0 to 12.3)5.9 (2.4 to 14.2)
P valueb0.600.450.21
Diastolic BP, mmHgn=35n=34n=33
 Unadjusted baseline, mean (SD)73.7 (11.8)70.0 (9.9)73.0 (13.1)
 Unadjusted 6 mo, mean (SD)75.1 (10.1)70.7 (9.1)75.0 (13.8)
 Unadjusted change (95% CI) at 6 moa1.4 (1.6 to 4.4)0.7 (2.3 to 3.8)2.0 (1.1 to 5.2)−0.7 (5.8 to 4.5)0.6 (4.6 to 5.8)1.3 (4.0 to 6.5)
P valuea0.830.960.83
 Adjusted change (95% CI) at 6 mob1.9 (0.8 to 4.6)−0.0 (2.8 to 2.8)2.3 (0.5 to 5.1)−1.9 (6.6 to 2.8)0.4 (4.3 to 5.1)2.3 (2.4 to 7.1)
P valueb0.590.980.48
Urine ACR, ln(mg/g)n=35n=31n=32
 Unadjusted baseline, mean (SD)5.3 (2.1)5.1 (1.6)5.2 (2.0)
 Unadjusted 6 mo, mean (SD)5.4 (2.1)5.0 (1.8)5.2 (2.1)
 Unadjusted change (95% CI) at 6 moa0.1 (0.1 to 0.3)−0.1 (0.3 to 0.1)0.0 (0.2 to 0.2)−0.2 (0.5 to 0.2)−0.1 (0.5 to 0.3)0.8 (0.3 to 0.5)
P valuea0.540.850.87
 Adjusted change (95% CI) at 6 mob0.1 (0.1 to 0.3)−0.1 (0.3 to 0.1)0.0 (0.2 to 0.2)−0.2 (0.5 to 0.2)−0.1 (0.5 to 0.3)0.8 (0.3 to 0.5)
P valueb0.540.850.87
Calcium, mg/dln=35n=34n=33
 Unadjusted baseline, mean (SD)9.3 (0.4)9.3 (0.5)9.2 (0.5)
 Unadjusted 6 mo, mean (SD)9.0 (1.2)9.4 (0.5)9.3 (0.5)
 Unadjusted change (95% CI) at 6 moa−0.3 (0.5 to 0.0)0.1 (0.2 to 0.4)0.1 (0.2 to 0.4)0.4 (0.1 to 0.8)0.4 (0.1 to 0.8)−0.0 (0.4 to 0.4)
P valuea0.100.11>0.99
 Adjusted change (95% CI) at 6 mob−0.3 (0.5 to 0.0)0.1 (0.1 to 0.4)0.1 (0.2 to 0.3)0.4 (0.0 to 0.8)0.4 (0.1 to 0.8)−0.0 (0.5 to 0.4)
P valueb0.090.120.99
Phosphate, mg/dln=35n=34n=33
 Unadjusted baseline, mean (SD)3.5 (0.7)3.4 (0.6)3.5 (0.7)
 Unadjusted 6 mo, mean (SD)3.6 (0.8)3.6 (0.8)3.6 (0.8)
 Unadjusted change (95% CI) at 6 moa0.2 (0.0 to 0.4)0.2 (0.0 to 0.4)0.2 (0.0 to 0.4)0.0 (0.3 to 0.3)−0.0 (0.4 to 0.3)−0.0 (0.4 to 0.3)
P valuea0.990.990.97
 Adjusted change (95% CI) at 6 mob0.2 (0.0 to 0.4)0.2 (0.0 to 0.4)0.2 (0.0 to 0.4)0.0 (0.3 to 0.3)−0.0 (0.3 to 0.3)−0.0 (0.4 to 0.3)
P valueb0.990.990.97
PTH, ln(pg/ml)n=35n=33n=33
 Unadjusted baseline, mean (SD)4.9 (0.7)4.6 (0.7)4.6 (0.7)
 Unadjusted 6 mo, mean (SD)5.0 (0.8)4.4 (0.8)4.1 (0.9)
 Unadjusted change (95% CI) at 6 moa0.1 (0.0 to 0.3)−0.3 (0.4 to 0.1)−0.5 (0.6 to 0.3)−0.4 (0.7 to 0.1)−0.6 (0.9 to 0.3)−0.2 (0.5 to 0.1)
P valuea<0.01<0.0010.24
 Adjusted change (95% CI) at 6 mob0.2 (0.0 to 0.3)−0.2 (0.4 to 0.1)−0.5 (0.6 to 0.3)−0.4 (0.7 to 0.1)−0.6 (0.9 to 0.3)−0.2 (−0.5 to 0.1)
P valueb<0.01<0.0010.22
FGF-23, ln(pg/ml)n=33n=32n=33
 Unadjusted baseline, mean (SD)5.0 (0.7)4.7 (0.9)4.7 (0.9)
 Unadjusted 6 mo, mean (SD)5.0 (0.9)4.9 (1.0)4.9 (0.9)
 Unadjusted change (95% CI) at 6 moa0.1 (−0.1 to 0.3)0.2 (0.0 to 0.3)0.2 (0.1 to 0.4)0.1 (−0.2 to 0.4)0.1 (−0.1 to 0.4)0.1 (−0.2 to 0.3)
P valuea0.700.410.89
 Adjusted change (95% CI) at 6 mob0.1 (−0.1 to 0.3)0.2 (0.0 to 0.3)0.2 (0.1 to 0.4)0.1 (−0.2 to 0.4)0.1 (−0.1 to 0.4)0.1 (−0.2 to 0.3)
P valueb0.710.430.89
CRP, ln(mg/L)n=34n=32n=33
 Unadjusted baseline, mean (SD)0.3 (1.0)0.4 (1.3)0.6 (1.2)
 Unadjusted 6 mo, mean (SD)0.2 (1.0)0.5 (1.1)0.6 (1.1)
 Unadjusted change (95% CI) at 6 moa−0.1 (−0.4 to 0.2)0.1 (−0.2 to 0.3)0.0 (−0.2 to 0.3)0.1 (−0.3 to 0.6)0.1 (−0.4 to 0.6)−0.0 (−0.5 to 0.4)
P valuea0.750.830.99
 Adjusted change (95% CI) at 6 mob−0.1 (−0.4 to 0.1)0.1 (−0.2 to 0.3)0.1 (−0.2 to 0.3)0.2 (−0.2 to 0.6)0.2 (−0.2 to 0.6)0.0 (−0.4 to 0.4)
P valueb0.540.51>0.99
25(OH)D, ng/mln=33n=32n=32
 Unadjusted baseline, mean (SD)29.1 (11.4)26.7 (10.8)25.8 (9.6)
 Unadjusted 6 mo, mean (SD)26.2 (11.6)23.8 (8.9)94.1 (51.9)
 Unadjusted change (95% CI) at 6 moa−2.9 (−13.0 to 7.2)−2.9 (−13.2 to 7.3)68.3 (58.1 to 78.6)−0.0 (−17.3 to 17.2)71.2 (54.0 to 88.5)71.3 (53.9 to 88.7)
P valuea>0.99<0.001<0.001
 Adjusted change (95% CI) at 6 mob−2.8 (−13.0 to 7.4)−2.9 (−13.2 to 7.4)68.3 (58.0 to 78.6)−0.1 (−17.5 to 17.3)71.1 (53.6 to 88.6)71.2 (53.7 to 88.7)
P valueb>0.99<0.001<0.001
1,25(OH)2D, pg/mln=33n=31n=32
 Unadjusted baseline, mean (SD)20.3 (7.4)21.7 (10.2)23.9 (10.9)
 Unadjusted 6 mo, mean (SD)21.7 (7.6)27.2 (10.9)27.5 (14.3)
 Unadjusted change (95% CI) at 6 moa1.4 (−2.6 to 5.4)5.5 (1.4 to 9.7)3.5 (−0.5 to 7.6)4.2 (−2.7 to 11.0)2.2 (−4.7 to 9.0)−2.0 (−8.9 to 5.0)
P valuea0.330.730.78
 Adjusted change (95% CI) at 6 mob0.5 (−3.1 to 4.1)5.4 (1.7 to 9.1)4.6 (0.9 to 8.3)4.9 (−1.3 to 11.1)4.1 (−2.1 to 10.4)−0.8 (−7.1 to 5.5)
P valueb0.150.250.95
  • SI conversion factors: to convert urine ACR to mg/mmol, multiply by 0.113; to convert calcium to mmol/L, multiply by 0.25; to convert phosphate to mmol/L, multiply by 0.323; to convert PTH to pmol/L, multiply by 0.106; to convert 25(OH)D to nmol/L, multiply by 2.496; to convert 1,25(OH)2D to pmol/L, multiply by 2.6. 95% CI, 95% confidence interval; ACR, albumin-to-creatinine ratio; PTH, parathyroid hormone; FGF-23, fibroblast growth factor 23; CRP, C-reactive protein; 25(OH)D, 25-hydroxyvitamin D; 1,25(OH)2D, 1,25-dihydroxyvitamin D.

  • a P values and 95% CIs adjusted for multiple comparisons using the Tukey–Kramer method.

  • b Analysis of covariance results: adjusted mean, 95% CI, and P value for treatment effects with the respective baseline value as covariate.