Table 1.
Clinical parameters during the four treatment periods: Intention-to-treat analysis
| Parameters | RS Diet | Sodium Restriction Diet | ||
|---|---|---|---|---|
| Placebo, n=44 | Paricalcitol, n=44 | Placebo, n=43 | Paricalcitol, n=43 | |
| Plasma/serum | ||||
| Hemoglobin, mmol/L | 9.0±0.9 | 9.0±0.8 | 9.1±0.9 | 9.0±0.8 |
| Sodium, mmol/L | 140.6±2.3 | 140.1±2.0 | 139.8±2.4a | 140.4±2.4b |
| Potassium, mmol/L | 4.3±0.4 | 4.2±0.4 | 4.3±0.4c | 4.4±0.5c |
| Calcium, mmol/L | 2.35±0.11 | 2.37±0.10 | 2.37±0.13 | 2.41±0.15a,b |
| Phosphate, mmol/L | 0.94±0.17 | 0.98±0.16a | 0.94±0.14 | 1.00±0.15a,b |
| Creatinine, μmol/L | 110±32 | 112±32 | 113±31 | 120±35a,b,c |
| eGFR, ml/min per 1.73 m2 | 68±25 | 67±24 | 67±24 | 63±25a,b,c |
| Albumin, g/L | 38±5 | 39±5 | 40±4a | 40±4a |
| Total cholesterol, mmol/L | 5.2±1.2 | 5.2±1.2 | 4.9±1.0a,c | 5.1±1.2b |
| HDL cholesterol, mmol/L | 1.4±0.4 | 1.4±0.4 | 1.3±0.4a,c | 1.3±0.4 |
| LDL cholesterol, mmol/L | 3.1±0.9 | 3.0±1.0 | 2.9±0.7a | 3.1±0.90 |
| Renin, pg/ml | 42.9 [30.9 to 59.5] | 45.3 [32.5 to 63.1] | 61.3 [44.6 to 84.2]a,c | 66.5 [48.4 to 91.4]a,c |
| PTH, pmol/L | 5.0 [4.4 to 5.7] | 3.5 [3.0 to 4.1]a | 5.5 [4.8 to 6.2]c | 3.4 [3.0 to 4.0]a,b |
| 25(OH)D, nmol/L | 50.4±22.8 | 50.6±23.4 | 52.7±22.6 | 56.4±24.2 |
| FGF-23, RU/ml | 114 [102 to 128] | 139 [122 to 158]a | 120 [106 to 135]a,c | 152 [130 to 178]a,b,c |
| Urine | ||||
| Creatinine, mmol/24 h | 14.7±3.9 | 14.5±3.8 | 13.8±3.7a | 14.4±3.4b |
| Sodium, mmol/24 h | 170±61 | 178±68 | 104±59a,c | 111±63a,c |
| Urea, mmol/24 h | 419±128 | 416±132 | 383±120a | 404±118 |
| Potassium, mmol/24 h | 78±25 | 80±25 | 81±26 | 82±24 |
| Calcium, mmol/24 h | 2.4±2.0 | 4.5±3.3a | 2.2±2.4c | 3.9±2.9a,b |
| Phosphate, mmol/24 h | 32.4±9.5 | 33.8±13.3 | 30.4±13.2 | 31.5±9.9 |
| Albuminuria, mg/24 h | 1060 [778 to 1443] | 990 [755 to 1299] | 717 [512 to 1005] | 683 [502 to 929] |
| Proteinuria, g/24 h | 1.4 [1.0 to 1.8] | 1.3 [1.0 to 1.6] | 1.0 [0.7 to 1.3]a,c | 0.9 [0.7 to 1.2]a,c |
| Albumin-to-creatinine ratio | 75 [55 to 101] | 71 [53 to 94] | 54 [39 to 75]a,c | 49 [36 to 66]a,c |
| Creatinine clearance, ml/min | 101±41 | 97±38 | 91±38a | 90±35a |
| Other | ||||
| Systolic BP, mmHg | 129±14 | 128±14 | 123±12a,c | 122±12a,c |
| Diastolic BP, mmHg | 77±9 | 78±11 | 74±9a,c | 74±9a,c |
| MAP, mmHg | 95±10 | 95±11 | 90±9a,c | 90±9a,c |
| Heart rate, bpm | 65±10 | 66±10 | 65±10 | 65±10 |
| Body weight, kg | 90±17 | 89±17 | 88±18a,c | 87±17a,c |
| Compliance, % | 95±7 | 97±6 | 97±5 | 97±4 |
Data are presented as mean±SD or geometric mean [95% CI] for normally or skewed distributed data, respectively. P value shows treatment effect by linear mixed modeling with center, treatment, sequence, and the interaction treatment × sequence as fixed factors.
a
P<0.05 versus placebo on RS diet.
b
P<0.05 versus placebo on sodium restriction diet.
c
P<0.05 versus paricalcitol on RS diet.