Table 1.
Participant Characteristics at Enrollment
| Daily Trial |
Nocturnal Trial |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All (N = 375) |
Randomly Assigned (n = 243) |
Enrolled Only (n = 37) |
Randomly Assigned (n = 84) |
Enrolled Only (n = 11) |
||||||
| Variables | No. | Value | No. | Value | No. | Value | No. | Value | No. | Value |
| Age (y) | 375 | 50.6 ± 13.7 | 243 | 50.3 ± 13.9 | 37 | 48.6 ± 13.1 | 84 | 52.3 ± 13.5 | 11 | 49.2 ± 13.4 |
| Men | 375 | 232 (62) | 243 | 150 (62) | 37 | 20 (54) | 84 | 55 (65) | 11 | 7 (64) |
| Black race | 375 | 143 (38) | 243 | 102 (42) | 37 | 16 (43) | 84 | 22 (26) | 11 | 3 (27) |
| ESRD vintage (y) | 375 | 2.67 (0.96, 6.15) | 243 | 3.64 (1.62, 7.55) | 37 | 1.85 (1.26, 4.64) | 84 | 0.86 (0.27, 3.53) | 11 | 1.71 (0.15, 10.6) |
| Primary language not English |
375 | 63 (17) | 243 | 48 (20) | 37 | 3 (8) | 84 | 10 (12) | 11 | 2 (18) |
| Education level | 367 | 240 | 34 | 83 | 10 | |||||
| >High school graduate | 211 (57) | 132 (55) | 24 (71) | 49 (59) | 6 (60) | |||||
| High school graduate | 86 (23) | 57 (24) | 5 (15) | 21 (25) | 3 (30) | |||||
| <High school graduate | 70 (19) | 51 (21) | 5 (15) | 13 (16) | 1 (10) | |||||
| Lives with family | 371 | 273 (74) | 243 | 166 (68) | 34 | 21 (62) | 84 | 78 (93) | 10 | 8 (80) |
| Insurance status | 372 | 243 | 35 | 84 | 10 | |||||
| Government insurance not awarded by income levela |
91 (24) | 52 (21) | 6 (17) | 29 (35) | 4 (40) | |||||
| Employer group health insurance or privately purchased |
123 (33) | 62 (26) | 12 (34) | 46 (55) | 3 (30) | |||||
| Government insurance for the poorb |
158 (42) | 129 (53) | 17 (49) | 9 (11) | 3 (30) | |||||
| Diabetes | 370 | 153 (41) | 243 | 98 (40) | 32 | 15 (47) | 84 | 35 (42) | 11 | 5 (45) |
| Congestive heart failure | 370 | 69 (19) | 243 | 48 (20) | 32 | 8 (25) | 84 | 11 (13) | 11 | 2 (18) |
| Peripheral arterial disease |
370 | 45 (12) | 243 | 25 (10) | 32 | 5 (16) | 84 | 13 (15) | 11 | 2 (18) |
| Stroke | 370 | 26 (7) | 243 | 19 (8) | 32 | 5 (16) | 84 | 2 (2) | 11 | 0 |
| enPCR (g/kg/d) | 371 | 1.04 ± 0.27 | 243 | 1.03 ± 0.25 | 33 | 1.07 ± 0.35 | 84 | 1.02 ± 0.28 | 11 | 1.20 ± 0.40 |
| Residual renal clearance (mL/min) |
372 | 0 (0, 1.22) | 243 | 0 (0, 0.72) | 34 | 0.49 (0, 5.30) | 84 | 1.13 (0, 2.71) | 11 | 0.83 (0, 3.00) |
| Creatinine (mg/dL) | 372 | 9.96 ± 2.96 | 243 | 10.6 ± 2.70 | 34 | 9.12 ± 3.36 | 84 | 8.83 ± 2.96 | 11 | 8.29 ± 3.29 |
| Phosphate (mg/dL) | 372 | 5.80 ± 1.68 | 243 | 5.78 ± 1.64 | 34 | 5.86 ± 2.08 | 84 | 5.80 ± 1.63 | 11 | 6.04 ± 1.85 |
| Hemoglobin (g/dL) | 346 | 11.9 ± 1.30 | 232 | 11.9 ± 1.30 | 27 | 12.1 ± 1.80 | 79 | 11.8 ± 1.10 | 8 | 12.5 ± 1.00 |
| PTH (pg/mL) | 364 | 317 (183, 548) | 243 | 313 (183, 616) | 27 | 398 (171, 584) | 84 | 326 (195, 439) | 10 | 204 (55.9, 293) |
| Albumin (g/dL) | 372 | 3.92 ± 0.43 | 243 | 3.94 ± 0.42 | 34 | 3.89 ± 0.36 | 84 | 3.91 ± 0.49 | 11 | 3.62 ± 0.48 |
| Calcium (mg/dL) | 364 | 8.96 ± 0.88 | 243 | 9.01 ± 0.92 | 27 | 9.01 ± 0.73 | 84 | 8.82 ± 0.79 | 10 | 8.67 ± 0.85 |
| Bicarbonate (mEq/L) | 363 | 23.3 ± 3.80 | 243 | 23.7 ± 3.70 | 26 | 22.3 ± 4.70 | 84 | 22.7 ± 3.70 | 10 | 22.0 ± 4.10 |
| LV mass (g) | 349 | 141 ± 53.0 | 243 | 141 ± 55.0 | 13 | 165 ± 65.0 | 84 | 137 ± 45.0 | 9 | 152 ± 56.0 |
| BMI (kg/m2) | 353 | 29.0 ± 7.70 | 233 | 28.7 ± 6.80 | 32 | 30.3 ± 11.6 | 79 | 29.5 ± 7.80 | 9 | 27.5 ± 11.3 |
| Phase angle (degrees) | 351 | 5.42 ± 1.50 | 233 | 5.43 ± 1.52 | 32 | 5.39 ± 1.46 | 77 | 5.52 ± 1.49 | 9 | 4.35 ± 1.23 |
| ICW volume/weight (dL/kg) |
351 | 0.260 ± 0.063 | 233 | 0.267 ± 0.062 | 32 | 0.257 ± 0.067 | 77 | 0.268 ± 0.066 | 9 | 0.260 ± 0.074 |
| PHC scorec | 375 | 37.4 ± 10.1 | 37 | 34.6 ± 9.8 | 37 | 34.6 ± 9.8 | 84 | 37.6 ± 9.0 | 11 | 29.7 ± 7.5 |
| PF scale scorec | 375 | 57.9 ± 26.0 | 243 | 58.1 ± 26.9 | 37 | 51.6 ± 27.1 | 84 | 61.9 ± 22.2 | 11 | 42.7 ± 24.0 |
| SPPB score | 375 | 243 | 37 | 84 | 11 | |||||
| 0-6 | 83 (22) | 60 (25) | 9 (24) | 10 (12) | 4 (36) | |||||
| 7-9 | 134 (36) | 80 (33) | 17 (46) | 36 (43) | 1 (9) | |||||
| 10-12 | 158 (42) | 103 (42) | 11 (30) | 38 (45) | 6 (55) | |||||
Note: Results are shown as mean ± standard deviation, median (25th, 75th percentiles), or frequency (percentage), as appropriate. Conversion factors for units: creatinine in mg/dL to μmol/L, ×88.4; hemoglobin and albumin in g/dL to g/L, ×10; calcium in mg/dL to mmol/L, ×0.2495. No conversion necessary for PTH in pg/mL and ng/L and bicarbonate in mEq/L and mmol/L.
Abbreviations: BMI, body mass index; enPCR, equilibrated normalized protein catabolic rate; ESRD, end-stage renal disease; ICW, intracellular water; LV, left ventricular; PF, Physical Functioning; PHC, physical health composite; PTH, parathyroid hormone; SPPB, Short Physical Performance Battery.
Medicare plus Canadian Health.
Medicaid and/or other state/county programs.
From the 36-Item Short Form Health Survey.