Je SH, et al. • Vitamin K Supplement and BMD, UcOC Changes Table 1. Characteristics of study participants at baseline by treatment group: ITT analysis Table 2. Characteristics of study participants at baseline by treatment group: PP anal- ysis P value Variables Variables Age (yr) Height (cm) Weight (kg) Age at menopause (yr) Duration of menopause (yr) SBP (mm/Hg) DBP (mm/Hg) Body mass index (kg/m2) Total cholesterol (mg/dL) BUN (mg/dL) Creatinine (mg/dL) HDL (mg/dL) Calcium (mg/dL) BMD (g/cm2) Lumbar 1 Lumbar 2 Lumbar 3 Lumbar 4 BMD femur neck (g/cm2) BMD femur ward (g/cm2) UcOC (ng/dL) Osteocalcin (ng/dL) BSALP (µg/liter) Vitamin K + D + Ca (n = 38) 68.1 ± 6.3 153.1 ± 4.9 56.0 ± 6.3 49.6 ± 2.7 18.4 ± 7.2 128.8 ± 27.0 75.0 ± 19.5 23.8 ± 2.5 198.4 ± 36.1 15.3 ± 4.0 0.8 ± 0.1 50.8 ± 10.3 9.0 ± 0.4 0.63 ± 0.10 0.70 ± 0.10 0.76 ± 0.11 0.82 ± 0.13 0.57 ± 0.07 0.39 ± 0.12 2.2 ± 1.8 10.9 ± 5.4 197.2 ± 54.4 Vitamin D + Ca (n = 40) 67.6 ± 6.2 153.2 ± 5.5 57.7 ± 7.6 50.8 ± 1.7 16.8 ± 6.8 119.2 ± 17.8 70.2 ± 10.5 24.5 ± 2.9 204.0 ± 36.6 15.3 ± 3.9 0.8 ± 0.1 52.9 ± 12.7 9.1 ± 0.2 0.62 ± 0.07 0.72 ± 0.10 0.77 ± 0.10 0.78 ± 0.10 0.58 ± 0.07 0.39 ± 0.09 1.6 ± 1.0 12.0 ± 6.3 184.2 ± 47.6 0.750 0.956 0.292 0.028 0.312 0.317 0.453 0.278 0.501 0.993 0.639 0.442 0.449 0.994 0.333 0.897 0.190 0.473 0.810 0.094 0.484 0.269 Age (yr) Height (cm) Weight (kg) Age at menopause (yr) Duration of menopause (yr) SBP (mm/Hg) DBP (mm/Hg) Body mass index (kg/m2) Total cholesterol (mg/dL) Triglyceride (mg/dL) BUN (mg/dL) Creatinine (mg/dL) HDL (mg/dL) Calcium (mg/dL) BMD (g/cm2) Lumbar 1 Lumbar 2 Lumbar 3 Lumbar 4 BMD femur neck (g/cm2) BMD femur ward (g/cm2) UcOC (ng/dL) Osteocalcin (ng/dL) BSALP (µg/liter) Vitamin K + D + Ca (n = 18) 67.3 ± 6.3* 153.7 ± 5.5 57.5 ± 4.9 50.6 ± 1.9 16.6 ± 6.8 128.7 ± 7.5 70.2 ± 13.6 24.3 ± 2.0 200.1 ± 39.8 142.4 ± 46.5 16.0 ± 4.2 0.7 ± 0.1 49.6 ± 10.8 9.0 ± 0.4 0.61 ± 0.11 0.69 ± 0.11 0.75 ± 0.13 0.79 ± 0.14 0.56 ± 0.07 0.38 ± 0.08 2.1 ± 1.7 9.6 ± 6.4 189.5 ± 64.5 Vitamin D + Ca (n = 27) 67.8 ± 6.4 153.4 ± 5.9 57.5 ± 8.2 51.0 ± 1.9 16.8 ± 7.0 122.8 ± 14.4 72.6 ± 8.5 24.3 ± 2.8 192.9 ± 32.8 136.5 ± 59.7 14.9 ± 4.1 0.8 ± 0.1 53.0 ± 13.8 9.1 ± 0.3 0.63 ± 0.08 0.72 ± 0.10 0.76 ± 0.09 0.77 ± 0.09 0.58 ± 0.06 0.39 ± 0.09 1.5 ± 1.0 11.7 ± 6.4 185.6 ± 46.0 P value 0.792 0.900 0.991 0.569 0.931 0.457 0.776 0.989 0.847 0.722 0.421 0.627 0.394 0.330 0.539 0.394 0.798 0.599 0.431 0.804 0.214 0.301 0.827 All values are mean ± standard deviation. P values are from independent t test. D, vitamin D; Ca, calcium supplement; SBP, systolic blood pressure; DBP, diastolic blood pressure; BUN, blood urea nitrogen; HDL, high-density lipoprotein; BMD, bone miner- al density; UcOC, undercarboxylated osteocalcin; BSALP, serum bone-specific alka- line phosphatase. from the age at menopause in the control group (50.8 ± 1.7 yr, P = 0.03). Other characteristics did not differ in the treatment group in both ITT and PP analyses. In the PP analysis (Table 2), char- acteristics of women in the vitamin K group were not different from those in the control group. The mean (± SD) age, age at menopause, and duration of menopause were 67.3 ± 6.3, 50.6 ± 1.9, and 16.6 ± 6.8 yr, respectively, in the vitamin K group and 67.8 ± 6.4, 51.0 ± 1.9, and 16.8 ± 7.0 yr, respectively, in the con- trol group. BMDs in lumbar and femur were similar in both the vitamin K and the control groups. In addition, the UcOC con- centration in the vitamin K group (2.1 ± 1.7 ng/dL) was not sig- nificantly different from that in the control group (1.5 ± 1.0 ng/ dL, P = 0.214). The mean (± SD) osteocalcin level was 9.6 ± 6.4 ng/dL in the vitamin K group and 11.7 ± 6.4 ng/dL in the con- trol group. There were no significant differences in blood urea nitrogen, creatinine, calcium and serum bone-specific alkaline phosphatase (BSALP) between the vitamin K and the control groups. The BMD in L1-L4 and femur neck, and in the ward in the vitamin K group were not different from those in the control group. The serum UcOC level in the vitamin K group (2.1 ± 1.7 ng/dL) was higher than that in the control group (1.5 ± 1.0 ng/ dL), but showed no significant difference (P = 0.21). Osteocalcin level was nonsignificantly lower in the vitamin K group (9.6 ± DOI: 10.3346/jkms.2011.26.8.1093 All values are mean ± standard deviation. P values were from independent t test. D, vitamin D; Ca, calcium supplement; SBP, systolic blood pressure; DBP, diastolic blood pressure; BUN, blood urea nitrogen; HDL, high-density lipoprotein; BMD, bone mineral density; UcOC, undercarboxylated osteocalcin; BSALP, serum bone-specific alkaline phosphatase. 6.4 ng/dL) than in the control group (11.7 ± 6.4 ng/dL, P = 0.29). The BSALP level was 189.5 ± 64.5 μg/L in the vitamin K group and 185.6 ± 46.0 μg/L in the control group (P = 0.827). No signif- icant differences in BMD and biomarker values between the vi- tamin K and the control groups indicated that the randomiza- tion worked well. The ITT analysis showed similar results. After 6 months of treatment, the L3 BMD in the vitamin K group compared to the control group increased statistically sig- nificantly (0.01 ± 0.03 g/cm2 vs -0.008 ± 0.04 g/cm2, P = 0.049). Compared to BMD at baseline, BMD in femur at month 6 was significantly increased in both the vitamin K and the control groups. However, after 6 months of treatment, BMD in the vita- min K group was not statistically different from BMD in the con- trol group. In addition, compared to the baseline, the vitamin K group significantly decreased UcOC concentration (-1.6 ± 1.6 ng/dL, P < 0.01), whereas the UcOC level in the control group did not change (-0.4 ± 1.1 ng/dL). The change in UcOC concen- tration in the vitamin K group, but not in the control group, con- firmed the compliance of the participants in the vitamin K group with the study protocol. Osteocalcin was also non-significantly increased in the vitamin K group (1.6 ± 5.8 ng/dL), but not in the control group (-1.1 ± 6.0 ng/dL). Triglyceride level decreased in the vitamin K group (-10.0 ± 59.1 ng/dL) (Table 3). Three people http://jkms.org 1095