Background
Methods
Trial design, participants and data collection
Definitions
Ethical considerations
Intervention
Analysis of dp-ucMGP and AC-24 score measurements
Adverse events and safety
Statistical analysis
Outcome measures
Results
Baseline demographics and clinical characteristics:
ALL N = 50 | |
---|---|
Age (years), median (IQR) | 71.50 (56.75; 79.25) |
Gender, male n (%) | 30 (60.0) |
Dialysis vintage (months), median (IQR) | 47.0 (26.5; 110.5) |
Diabetes, n (%) | 18 (36.0) |
Hypertension, n (%) | 38 (76.0) |
Smoking, n (%) | 8 (16.0) |
Calcification score, median (IQR) | 7.0 (2.0; 13.25) |
Baseline dp-ucMGP (pM), median (IQR) | 3179.15 (1825.25; 4339.50) |
NCBB, n (%) | 20 (40.0) |
Residual diuresis, n (%) | 6 (12.0) |
Calcium dose (tablets of 600 mg), median (IQR) | 1.00 (1.00; 2.25) |
Alfacalcidol dose (μg), median (IQR) | 0.75 (0.00; 1.50) |
Serum phosphate (mg/dl), median (IQR) | 3.90 (3.17; 4.65) |
Serum calcium (mg/dl), median (IQR) | 9.10 (8.80; 9.30) |
PTH (pg/ml), median (IQR) | 188.50 (117.75; 266.50) |
LDL cholesterol (mg/dl), median (IQR) | 92.0 (77.0; 113.0) |
BMI (Kg/m2), median (IQR) | 25.82 (22.85; 28.42) |
URR, median (IQR) | 75.0 (71.0; 79.0) |
Albumin (g/l), median (IQR) | 39.0 (36.0; 41.0) |
CAD, n (%) | 14 (28.0) |
Cinacalcet, n (%) | 2 (4.0) |
Previous acenocoumadin, n (%) | 6 (12.0) |
PTHX, n (%) | 2 (4.0) |
Recent fracture, n (%) | 3 (6.0) |
Bivariate regression analysis between different groups of dp-ucMGP levels (Table 2, Table 3, Table 4)
Baseline dp-ucMGP <5000 N = 41 | Baseline dp-ucMGP >5000 N = 9 |
P-value | |
---|---|---|---|
Age (years), median (IQR) | 69.0 (56.5; 76.5) | 80.0 (57.0; 82.5) | 0.18 |
Gender, male n (%) | 28 (68.3) | 2 (22.2) | 0.02 |
Dialysis vintage (months), median (IQR) | 43.0 (20.5; 104.0) | 82.0 (41.0; 134.0) | 0.18 |
Diabetes, n (%) | 16 (39.0) | 2 (22.2) | 0.46 |
Hypertension, n (%) | 34 (82.9) | 4 (44.4) | 0.03 |
Smoking, n (%) | 6 (14.6) | 2 (22.2) | 0.62 |
Calcification score, median (IQR) | 7.0 (2.0; 12.5) | 13.0 (2.5; 21.0) | 0.25 |
NCBB, n (%) | 16 (39.0) | 4 (44.4) | 1.00 |
Residual diuresis, n (%) | 5 (12.2) | 1 (11.1) | 1.00 |
Calcium dose (tablets of 600 mg), median (IQR) | 1.0 (1.0; 3.0) | 1.0 (0.0; 1.0) | 0.055 |
Alfacalcidol dose (μg), median (IQR) | 0.75 (0.00; 1.25) | 1.0 (0.5; 5.0) | 0.08 |
Serum phosphate (mg/dl), median (IQR) | 3.9 (3.3; 4.8) | 3.90 (2.75; 4.40) | 0.29 |
Serum calcium (mg/dl), median (IQR) | 9.1 (8.8; 9.3) | 9.2 (8.8; 9.6) | 0.40 |
PTH (pg/ml), median (IQR) | 163.0 (95.2; 260.0) | 197.0 (165.5; 397.0) | 0.27 |
LDL cholesterol (mg/dl), median (IQR) | 92.0 (77.0; 113.0) | 92.0 (67.0; 113.0) | 0.82 |
BMI, median (IQR) | 25.6 (22.8; 27.8) | 26.16 (23.35; 33.56) | 0.18 |
URR, median (IQR) | 74.0 (71.0; 78.0) | 77.0 (75.0; 80.5) | 0.08 |
Albumin, median (IQR) | 39.0 (37.0; 41.5) | 36.5 (34.0; 39.0) | 0.046 |
CAD, n (%) | 11 (26.8) | 3 (33.3) | 0.70 |
Cinacalcet, n (%) | 1 (2.4) | 1 (11.1) | 0.33 |
Previous acenocoumadin, n (%) | 4 (9.8) | 2 (22.2) | 0.29 |
PTHX, n (%) | 2 (4.9) | 0 (0.0) | 1.00 |
Recent fracture, n (%) | 0 (0.0) | 3 (33.3) | 0.004 |
Baseline dp-ucMGP <1000 N = 5 | Baseline dp-ucMGP >1000 N = 45 |
P-value | |
---|---|---|---|
Age (years), median (IQR) | 55.0 (38.0; 64.0) | 73.0 (61.0; 80.0) | 0.02 |
Gender, male n (%) | 3 (60.0) | 27 (60.0) | 1.00 |
Dialysis vintage (months), median (IQR) | 36.0 (9.5; 152.0) | 47.0 (28.5; 108.5) | 0.73 |
Diabetes, n (%) | 2 (40.0) | 16 (35.6) | 1.00 |
Hypertension, n (%) | 3 (60.0) | 35 (77.8) | 0.58 |
Smoking, n (%) | 0 (0.0) | 8 (17.8) | 0.58 |
Calcification score, median (IQR) | 1.0 (0.5; 5.5) | 8.0 (2.0; 14.0) | 0.02 |
NCBB, n (%) | 2 (40.0) | 18 (40.0) | 1.00 |
Residual diuresis, n (%) | 0 (0.0) | 6 (13.3) | 1.00 |
Calcium dose (tablets of 600 mg), median (IQR) | 3.0 (1.5; 3.0) | 1.0 (1.0; 2.0) | 0.04 |
Alfacalcidol dose (μg), median (IQR) | 0.75 (0.25; 1.87) | 0.75 (0.00; 1.50) | 0.90 |
Serum phosphate (mg/dl), median (IQR) | 3.9 (3.6; 6.6) | 3.9 (3.0; 4.6) | 0.29 |
Serum calcium (mg/dl), median (IQR) | 9.3 (9.05; 9.65) | 9.1 (8.8; 9.2) | 0.09 |
PTH (pg/ml), median (IQR) | 127.0 (82.5; 297.0) | 196.0 (118.0; 270.0) | 0.29 |
LDL cholesterol (mg/dl), median (IQR) | 80.0 (72.0; 113.0) | 93.0 (77.0; 113.0) | 0.59 |
BMI (Kg/m2), median (IQR) | 30.2 (17.9; 34.3) | 25.8 (22.9; 27.8) | 0.69 |
URR, median (IQR) | 71.0 (65.0; 81.5) | 75.0 (72.0; 79.0) | 0.46 |
Albumin, median (IQR) | 40.0 (35.5; 44.5) | 39.0 (36.0; 41.0) | 0.44 |
CAD, n (%) | 1 (20.0) | 13 (28.9) | 1.00 |
Cinacalcet, n (%) | 0 (0.0) | 2 (4.4) | 1.00 |
Previous acenocoumadin, n (%) | 2 (40.0) | 4 (8.9) | 0.10 |
PTHX, n (%) | 0 (0.0) | 2 (4.4) | 1.00 |
Recent fracture, n (%) | 0 (0.0) | 3 (6.7) | 1.00 |
Baseline dp-ucMGP <3000 N = 24 | Baseline dp-ucMGP >3000 N = 26 |
P-value | |
---|---|---|---|
Age (years), median (IQR) | 69.0 (53.5; 76.5) | 73.5 (61.7; 80.0) | 0.28 |
Gender, male n (%) | 17 (70.8) | 13 (50.0) | 0.16 |
Dialysis vintage (months), median (IQR) | 40.0 (17.0; 99.2) | 49.5 (37.7; 119.0) | 0.15 |
Diabetes, n (%) | 11 (45.8) | 7 (26.9) | 0.24 |
Hypertension, n (%) | 18 (75.0) | 20 (76.9) | 1.00 |
Smoking, n (%) | 3 (12.5) | 5 (19.2) | 0.70 |
Calcification score, median (IQR) | 4.5 (1.0; 10.7) | 10.5 (3.7; 15.2) | 0.04 |
NCBB, n (%) | 11 (45.8) | 9 (34.6) | 0.56 |
Residual diuresis, n (%) | 4 (16.7) | 2 (7.7) | 0.41 |
Calcium dose (tablets of 600 mg), median (IQR) | 2.0 (1.0; 3.0) | 1.0 (1.0; 2.0) | 0.10 |
Alfacalcidol dose (μg), median (IQR) | 0.75 (0.00; 1.50) | 0.75 (0.25; 1.50) | 0.69 |
Serum phosphate (mg/dl), median (IQR) | 3.85 (3.50; 5.07) | 3.9 (3.0; 4.5) | 0.20 |
Serum calcium (mg/dl), median (IQR) | 9.0 (8.7; 9.3) | 9.15 (8.90; 9.32) | 0.13 |
PTH (pg/ml), median (IQR) | 158.5 (97.1; 260.2) | 205.0 (126.0; 319.0) | 0.38 |
LDL cholesterol (mg/dl), median (IQR) | 93.5 (77.7; 115.0) | 92.0 (76.0; 113.0) | 0.56 |
BMI (Kg/m2), median (IQR) | 25.57 (22.74; 29.64) | 26.02 (22.76; 28.42) | 0.74 |
URR, median (IQR) | 75.0 (69.5; 78.7) | 75.00 (71.25; 79.25) | 0.76 |
Albumin, median (IQR) | 39.0 (35.2; 41.0) | 38.50 (36.00; 41.25) | 0.99 |
CAD, n (%) | 6 (25.0) | 8 (30.8) | 0.76 |
Cinacalcet, n (%) | 1 (4.2) | 1 (3.8) | 1.00 |
Previous acenocoumadin, n (%) | 3 (12.5) | 3 (11.5) | 1.00 |
PTHX, n (%) | 0 (0.0) | 2 (7.7) | 0.49 |
Recent fracture, n (%) | 0 (0.0) | 3 (11.5) | 0.24 |
Drop of dp-ucMGP after 4 weeks of vitamin K2 supplementation
Dp-ucMGP drop ≤90% N = 23 | Dp-ucMGP drop >90% N = 27 |
P-value
|
OR (95% CI)
| |
---|---|---|---|---|
Age (years), Median (IQR) | 72.0 (55.0; 80.0) | 69.0 (63.0; 79.0) | 0.63 | 1.01 (0.97–1.05) |
Gender, male n (%) | 14 (60) | 16 (59.3) | 1.00 | 1.07 (0.34–3.33) |
Dialysis vintage (months), Median (IQR) | 41.0 (28.0; 112.0) | 48.0 (22.0; 110.0) | 0.68 | 1.02 (0.92–1.14) |
Diabetes, n (%) | 13 (56.5) | 5 (18.5) | 0.01 | 0.17 (0.05–0.62) |
Hypertension, n (%) | 16 (69.6) | 22 (81.5) | 0.32 | 1.92 (0.52–7.18) |
Smoking, n (%) | 3 (13.0) | 5 (18.5) | 0.71 | 1.51 (0.32–7.17) |
Calcification score, Median (IQR) | 3.0 (1.0; 12.0) | 9.0 (4.0; 14.0) | 0.10 | 1.06 (0.97–1.15) |
NCBB, n (%) | 10 (43.5) | 10 (37.0) | 0.64 | 0.76 (0.25–2.38) |
Residual diuresis, n (%) | 3 (13.0) | 3 (11.1) | 1.00 | 0.83 (0.15–4.59) |
Calcium dose, Median (IQR) | 2.0 (1.0; 3.0) | 1.0 (1.0; 2.0) | 0.12 | 0.63 (0.36–1.11) |
Alfacalcidol dose (μg), Median (IQR) | 0.75 (0.00; 1.50) | 0.75 (0.25; 1.50) | 0.20 | 1.17 (0.82–1.69) |
Serum phosphate (mg/dl), Median (IQR) | 3.90 (3.50; 5.00) | 3.90 (3.00; 4.50) | 0.25 | 0.64 (0.39–1.06) |
Serum calcium (mg/dl), Median (IQR) | 9.00 (8.70; 9.30) | 9.20 (8.90; 9.30) | 0.08 | 4.97 (0.82–30.06) |
PTH (pg/ml), Median (IQR) | 153.00 (88.50; 216.00) | 216.0 (144.0; 314.0) | 0.10 | 1.03 (0.98–1.07) |
LDL cholesterol (mg/dl), Median (IQR) | 93.50 (77.75; 114.25) | 92.00 (76.00; 113.25) | 0.61 | 0.99 (0.97–1.02 |
BMI (Kg/m2), Median (IQR) | 26.45 (23.03; 31.39) | 25.26 (22.65; 26.65) | 0.13 | 0.89 (0.78–1.01) |
URR, Median (IQR) | 75.0 (71.0; 79.0) | 74.0 (71.0; 79.0) | 0.70 | 0.98 (0.88–1.10) |
Albumin, Median (IQR) | 37.0 (35.0; 40.0) | 39.0 (37.0; 41.0) | 0.15 | 1.09 (0.94–1.26) |
CAD, n (%) | 7 (30.4) | 7 (25.9) | 0.72 | 0.80 (0.23–2.76) |
Cinacalcet, n (%) | 1 (4.3) | 1 (3.7) | 1.00 | 0.85 (0.05–14.33) |
Previous acenocoumadin, n (%) | 3 (13.0) | 3 (11.1) | 1.00 | 0.83 (0.15–4.59) |
PTHX, n (%) | 0 (0.0) | 2 (7.4) | 0.49 | NA |
Recent fracture, n (%) | 1 (4.3) | 2 (7.4) | 1.00 | 1.76 (0.15–20.76) |
Drop MGP (reference: ≤90%) | ||
---|---|---|
Variables | OR (95% CI) |
P-value |
Diabetes | 0.17 (0.05–0.62) | 0.01 |