Table 2.
Biochemical serum safety parameters
| Normal range | Placebo (n = 37) | ch-OSA | ||||||||
| 3 mg Si (n = 33) | 6 mg Si (n = 33) | 12 mg Si (n = 33) | ||||||||
| LL | UL | Baseline | T12 | Baseline | T12 | Baseline | T12 | Baseline | T12 | |
| Serology | ||||||||||
| Glucose (mg/dL) | 70 | 110 | 87,43 ± 8,41 | 87,27 ± 6,74 | 89,03 ± 14,39 | 88,00 ± 10,32 | 86,50 ± 8,08 | 84,38 ± 9,23 | 86,16 ± 10,16 | 86,69 ± 9,72 |
| Urea (mg/dL) | 50,1 | 32,27 ± 8,66 | 32,39 ± 8,60 | 30,05 ± 8,51 | 32,46 ± 7,40 | 28,07 ± 7,45 | 30,33 ± 8,17(a) | 31,71 ± 7,12 | 30,54 ± 5,93 | |
| Creatinine (mg/dL) | 0,60 | 1,40 | 0,79 ± 0,13 | 0,83 ± 0,11(a) | 0,76 ± 0,14 | 0,84 ± 0,13(a) | 0,72 ± 0,12 | 0,79 ± 0,11(a) | 0,80 ± 0,12 | 0,82 ± 0,09 |
| Uric acid (mg/dL) | 2,6 | 7,2 | 5,53 ± 1,07 | 5,52 ± 1,00 | 5,92 ± 1,38 | 6,23 ± 1,51 | 5,25 ± 1,07 | 5,09 ± 1,05 | 5,88 ± 1,01 | 5,71 ± 0,99 |
| Ferritin (μg/L) | 11 | 250 | 60,24 ± 38,75 | 52,38 ± 33,81(a) | 63,84 ± 37,24 | 59,72 ± 36,12 | 44,97 ± 26,98 | 43,97 ± 32,96 | 77,09 ± 57,98 | 66,47 ± 49,59(a) |
| Total proteins (g/dL) | 6,4 | 8,3 | 7,14 ± 0,51 | 7,08 ± 0,37 | 7,00 ± 0,67 | 7,15 ± 0,32 | 7,20 ± 0,44 | 7,00 ± 0,32(a) | 7,21 ± 0,36 | 7,13 ± 0,49 |
| Cholesterol (mg/dL) | 190 | 241,59 ± 52,41 | 236,03 ± 52,09 | 223,22 ± 49,28 | 226,53 ± 34,47 | 241,47 ± 35,61 | 224,69 ± 26,44 (a) | 238,25 ± 35,48 | 226,69 ± 33,52 | |
| Triglycerides (mg/dL) | 180 | 105,49 ± 41,12 | 107,89 ± 51,95 | 130,28 ± 140,94 | 108,63 ± 61,67 | 100,59 ± 41,99 | 100,38 ± 40,21 | 101,81 ± 52,76 | 116,19 ± 110,20 | |
| HDL-cholesterol (mg/dL) | 40 | 50,11 ± 12,59 | 54,86 ± 12,58 (a) | 48,84 ± 18,54 | 55,28 ± 15,43 (a) | 53,13 ± 15,57 | 54,59 ± 12,94 | 47,53 ± 14,14 | 52,69 ± 14,58(a) | |
| LDL-cholesterol (mg/dL) | 115 | 169,95 ± 47,83 | 159,11 ± 46,14 (a) | 152,87 ± 45,41 | 150,90 ± 35,71 | 167,88 ± 31,09 | 149,69 ± 24,62 (a) | 169,61 ± 31,09 | 152,74 ± 34,18(a) | |
| HDL/LDL | 0,32 ± 0,12 | 0,38 ± 0,15(a) | 0,36 ± 0,17 | 0,40 ± 0,18 (a) | 0,33 ± 0,12 | 0,38 ± 0,12 (a) | 0,30 ± 0,10 | 0,37 0,13 (a) | ||
| Bilirubin total (mg/dL) | 0,1 | 1,3 | 0,43 ± 0,17 | 0,43 ± 0,17 | 0,39 ± 0,17 | 0,40 ± 0,16 | 0,43 ± 0,18 | 0,38 ± 0,11 (a) | 0,46 ± 0,23 | 0,51 ± 0,33 |
| SGOT (AST) (U/L) | 37 | 11,27 ± 3,44 | 13,11 ± 3,03(a) | 11,59 ± 4,15 | 13,44 ± 4,41(a) | 10,88 ± 2,88 | 12,34 ± 3,46 (a) | 11,28 ± 3,99 | 12,72 ± 3,74(a) | |
| SGPT (ALT) (U/L) | 38 | 9,57 ± 4,38 | 8,00 ± 4,01(a) | 9,91 ± 5,29 | 8,69 ± 4,50 | 8,75 ± 4,44 | 8,09 ± 2,91 | 10,16 ± 5,12 | 8,56 ± 3,75 (a) | |
| SGOT/SGPT | 1,38 ± 0,68 | 1,99 ± 0,91(a) | 1,46 ± 0,75 | 1,93 ± 0,97(a) | 1,55 ± 0,78 | 1,73 ± 0,78 | 1,46 ± 0,51 | 1,71 ± 0,74(a) | ||
| GGT (U/L) | 57 | 27,89 ± 19,64 | 25,27 ± 12,71 | 31,13 ± 41,16 | 31,19 ± 46,32 | 30,75 ± 56,18 | 34,31 ± 71,67 | 34,72 ± 44,76 | 34,88 ± 42,45 | |
| Cholinesterase (U/L) | 3930 | 11500 | 7785,5 ± 1547,5 | 7517,7 ± 1582,5 | 7235,4 ± 1987,2 | 7425,44 ± 1628,08 | 7356,2 ± 1668,9 | 7061,4 ± 1366,8 | 7178,8 ± 1320,6 | 7063,3 ± 1075,9 |
| Amylase (U/L) | 100 | 57,03 ± 17,15 | 56,22 ± 15,92 | 115,81 ± 317,01 | 128,16 ± 372,96 | 59,13 ± 22,08 | 58,53 ± 22,46 | 63,88 ± 21,48 | 62,66 ± 21,72 | |
| Lipase (U/L) | 7 | 60 | 30,22 ± 15,18 | 27,35 ± 8,30 | 32,25 ± 14,01 | 32,09 ± 12,64 | 31,00 ± 15,38 | 29,44 ± 14,72 | 30,59 ± 13,29 | 28,19 ± 10,31 |
| Trypsin (μg/L) | 10 | 57 | 44,23 ± 12,81 | 46,31 ± 10,56 | 49,19 ± 12,50 | 52,21 ± 12,78 | 44,58 ± 10,36 | 48,49 ± 18,86 | 43,86 ± 12,36 | 45,14 ± 11,74 |
| Sodium (mmol/L) | 135 | 145 | 139,70 ± 3,65 | 139,89 ± 5,29 | 137,03 ± 6,99 | 140,63 ± 1,90 (a) | 139,75 ± 4,18 | 140,59 ± 2,56 | 140,00 ± 2,87 | 140,63 ± 2,57 |
| Potassium (mmol/L) | 3,5 | 5,1 | 3,99 ± 0,24 | 3,97 ± 0,25 | 3,89 ± 0,36 | 3,96 ± 0,24 | 3,86 ± 0,25 | 3,98 ± 0,21 (a) | 3,90 ± 0,22 | 3,89 ± 0,25 |
| Calcium (mg/L) | 86 | 100 | 91,81 ± 5,35 | 92,73 ± 5,89 | 90,69 ± 9,42 | 93,69 ± 6,40 | 93,16 ± 4,01 | 93,31 ± 4,59 | 94,50 ± 3,32 | 93,41 ± 4,32 |
| Phosphorus (mg/dL) | 2,7 | 4,5 | 3,60 ± 0,44 | 3,70 ± 0,43 | 3,53 ± 0,55 | 3,65 ± 0,46 | 3,59 ± 0,43 | 3,70 ± 0,43 | 3,62 ± 0,40 | 3,63 ± 0,44 |
| Cupper (μg/dL) | 70 | 155 | 91,57 ± 14,43 | 108,19 ± 16,23 (a) | 101,50 ± 35,66 | 111,44 ± 24,69 (a) | 85, 48 ± 13,75 | 101,81 ± 16,70 (a) | 93,56 ± 15,15 | 110,63 ± 14,03 (a) |
| Magnesium (mg/dL) | 1,6 | 2,5 | 2,06 ± 0,14 | 1,95 ± 0,17(a) | 1,98 ± 0,22 | 1,92 ± 0,17 | 2,05 ± 0,20 | 1,92 ± 0,14 (a) | 1,99 ± 0,18 | 1,92 ± 0,18 (a) |
| Zinc (μg/dL) | 50 | 120 | 67,59 ± 7,77 | 75,08 ± 11,00 (a) | 66,19 ± 10,64 | 72,63 ± 11,96 (a) | 64,50 ± 9,80 | 68,63 ± 8,17 (a) | 63,00 ± 7,34 | 67,00 ± 9,42 |
| 25-OH-vit. D3 (ng/mL) | 6,3 | 46,4 | 19,26 ± 7,30 | 25,43 ± 8,03 (a) | 17,02 ± 7,21 | 26,31 ± 5,47(a) | 16,76 ± 9,62 | 25,83 ± 8,40 (a) | 18,78 ± 9,63 | 26,21 ± 6,52 (a) |
Baseline biochemical safety parameters in serum and after 12 months treatment with placebo (Ca/vit D) and three different ch-OSA doses (Si + Ca/vit D; Si: 3, 6, 12 mg/day), mean ± SD. LL: Lower limit; UL: Upper limit; (a) p < 0.05 versus baseline (two-tailed t-test).