Table 2. Summary of the outcome measurements overtime (baseline, 6 months and 12 months) – Intention-to-treat analysis.
Intervention (n = 93) | Placebo (n = 99) | Mean difference(95% CI) betweentreatment groupa | |
Mean (95% CI) | Mean (95% CI) | ||
Se 25(OH)D (nmol/l) | |||
Baseline | 30.19 (28.56 to 31.82) | 29.98 (27.20 to 32.78) | 0.19 (–2.43 to 2.82 |
6 month | 83.91 (79.84 to 87.97) | 37.15 (34.39 to 39.90) | 46.92 (42.42 to 51.43) |
12 months | 85.74 (81.25 to 90.22) | 36.09 (33.63 to 38.55) | 49.54 (43.94 to 55.14) * |
Se PTH (pmol/l) | |||
Baseline | 4.60 (4.18 to 5.03) | 4.76 (4.34 to 5.18) | –0.16 (–0.76 to 0.45) |
6 month | 4.58 (4.05 to 5.10) | 5.86 (5.34 to 6.38) | –1.28 (–2.02 to −0.55) * |
12 months | 4.19 (3.74 to 4.66) | 5.22 (4.77 to 5.67) | –1.02 (–1.67 to −0.38) * |
Se calcium (mmol/l) | |||
Baseline | 2.18 (2.17 to 2.19) | 2.19 (2.18 to 2.21) | –0.01 (–0.03 to 0.009) |
6 month | 2.23 (2.21 to 2.26) | 2.24 (2.21 to 2.26) | –0.005 (–0.04 to 0.03) |
12 months | 2.24 (2.22 to 2.26) | 2.22 (2.20 to 2.24) | 0.02 (–0.01 to 0.05) |
BMI | |||
Baseline | 27.22 (26.14 to 28.31) | 27.23 (26.18 to 28.28) | –0.005 (–1.511 to 1.500) |
6 month | 28.08 (26.96 to 29.19) | 27.76 (26.67 to 28.86) | 0.313 (–1.251 to 1.877) |
12 months | 27.63 (26.45 to 28.78) | 27.84 (26.73 to 28.95) | –0.209 (–1.807 to 1.389) |
Systolic BP | |||
Baseline | 121.6 (118.4 to 124.8) | 118.9 (115.8 to 121.9) | 2.71 (–1.71 to 7.13) |
6 month | 126.3 (122.9 to 129.6) | 123.9 (120.7 to 127.2) | 2.38 (–2.27 to 7.04) |
12 months | 125.8 (122.6 to 128.9) | 123.9 (120.8 to 126.9) | 1.89 (–2.56 to 6.35) |
Diastolic BP | |||
Baseline | 77.77 (75.56 to 79.99) | 76.79 (74.65 to 78.94) | 0.976 (–2.107 to 4.059) |
6 month | 79.74 (77.38 to 82.10) | 79.23 (76.97 to 81.55) | 0.508 (–2.805 to 3.820) |
12 months | 77.52 (75.22 to 79.81) | 76.76 (74.53 to 78.99) | 0.757 (–2.441 to 3.954) |
Se Glucose (mmol/l) | |||
Baseline | 5.07 (4.88 to 5.25) | 4.93 (4.75 to 5.12) | 0.13 (–0.13 to 0.39) |
6 month | 5.14 (4.97 to 5.32) | 5.07 (4.89 to 5.24) | 0.07 (–0.17 to 0.32) |
12 months | 5.04 (4.83 to 5.26) | 5.11 (4.90 to 5.32) | –0.07 (–0.37 to 0.23) |
Se insulin (mU/L | |||
Baseline | 13.81 (10.38 to 17.24) | 11.07 (7.74 to 14.39) | 2.74 (–2.04 to 7.51) |
6 month | 13.11 (11.18 to 15.04) | 12.17 (10.27 to 14.06) | 0.943 (–1.75 to 3.65) |
12 months | 13.93 (11.47 to 16.38) | 12.74 (10.36 to 15.12) | 1.19 (–2.23 to 4.61) |
HOMA-IR | |||
Baseline | 3.72 (2.25 to 5.19) | 2.47 (1.04 to 3.91) | 1.25 (–0.81 to 3.31) |
6 month | 3.12 (2.57 to 3.67) | 2.84 (2.29 to 3.38) | 0.28 (–0.49 to 1.05) |
12 months | 3.19 (2.61 to 3.78) | 2.99 (2.42 to 3.56) | 0.21 (–0.61 to 1.03) |
TG (mmol/l) | |||
Baseline | 1.15 (1.03 to 1.26) | 1.17 (1.06 to 1.29) | –0.03 (–0.19 to 0.14) |
6 month | 1.38 (1.25 to 1.51) | 1.19 (1.07 to 1.32) | 0.19 (0.01 to 0.37) * |
12 months | 1.36 (1.23 to 1.49) | 1.22 (1.09 to 1.35) | 0.14 (–0.33 to 0.33) |
HDL-C (mmol/l) | |||
Baseline | 1.45 (1.36 to 1.54) | 1.44 (1.35 to 1.52) | 0.01 (–0.11 to 0.13) |
6 month | 1.43 (1.36 to 1.49) | 1.50 (1.44 to 1.57) | –0.08 (–0.18 to 0.02) |
12 months | 1.52 (1.44 to 1.59) | 1.53 1.50 (1.43 to 1.58) | 0.02 (–0.09 to 0.13) |
LDL-C (mmol/l) | |||
Baseline | 3.26 (3.11 to 3.41) | 3.34 (3.19 to 3.48) | –0.08 (–0.29 to 0.13) |
6 month | 3.25 (3.09 to 3.39) | 3.31 (3.17 to 3.46) | –0.07 (–0.28 to 0.15) |
12 months | 3.62 (3.44 to 3.79) | 3.63 (3.46 to 3.80) | –0.01 (–0.26 to 0.23) |
*Significant at p<0.05.
Determined with linear mixed effect.