Table 4.
Safety profile and metabolic panel for Active treatment and Placebo at baseline and week 12.
| Test * | Baseline | Week 12 | ||||
|---|---|---|---|---|---|---|
| Active # | Placebo # | p-Value | Active # | Placebo # | p-Value | |
| Haemoglobin (115–160 g/L) |
146 ± 11 (128–165) |
145 ± 12 (124–167) |
0.807 | 145 ± 13 (123–166) |
141 ± 9 (130–175) |
0.225 |
| Red Cell Count (3.6–5.2 × 1012/L) |
4.9 ± 0.5 (4.4–6.2) |
4.9 ± 0.5 (4.2–6.2) |
0.717 | 4.9 ± 0.5 (3.8–5.6) |
4.7 ± 0.4 (3.9–5.8) |
0.204 |
| Haematocrit (0.33–0.46) |
0.45 ± 0.03 (0.39–0.51) |
0.44 ± 0.04 (0.38–0.51) |
0.645 | 0.44 ± 0.03 (0.36–0.51) |
0.43 ± 0.03 (0.39–0.51) |
0.251 |
| Mean Cell Volume (80–98 fL) |
91 ± 4.3 (82–100) |
91 ± 3.4 (82–97) |
0.889 | 91 ± 4 (86–100) |
92 ± 4 (86–102) |
0.430 |
| Mean Cell Haemoglobin (27–35 pg) |
29.9 ± 1.5 (26–32) |
30.1 ± 1.5 (27–33) |
0.699 | 30 ± 2 (28–34) |
30.2 ± 1.7 (28–34) |
0.515 |
| Platelet Count (150–450 × 109/L) |
266 ± 56 (171–385) |
260 ± 48 (156–371) |
0.697 | 271 ± 57 (131–326) |
253 ± 48 (154–344) |
0.264 |
| White Blood Cells (4.0–11.0 × 109/L) |
6.6 ± 1.4 (4.4–8.9) |
7.2 ± 1.8 (4.1–10.8) |
0.230 | 6.8 ± 1.9 (4.3–9.7) |
7.1 ± 1.3 (3.8–12) |
0.593 |
| Neutrophils (2.0–7.5 × 109/L) |
3.6 ± 0.9 (2.10–5.2) |
4.1 ± 1.1 (2.3–8.5) |
0.070 | 3.8 ± 1.7 (2.1–5.8) |
4.0 ± 1.0 (1.7–5.6) |
0.625 |
| Lymphocytes (1.1–4.0 × 109/L) |
2.2 ± 0.6 (1–3.4) |
2.3 ± 0.9 (1.1–3.8) |
0.674 | 2.2 ± 0.6 (1.1–3.9) |
2.2 ± 0.7 (1.3–5.5) |
0.893 |
| Monocytes (0.2–1.0 × 109/L) |
0.58 ± 0.14 (0.4–0.8) |
0.58 ± 0.24 (0.3–1.4) |
0.916 | 0.66 ± 0.27 (0.4–1.6) |
0.59 ± 0.56 (0.3–1.4) |
0.363 |
| Eosinophils (0.04–0.40 × 109/L) |
0.24 ± 0.17 (0.0–0.7) |
0.20 ± 0.17 (0.0–0.7) |
0.459 | 0.24 ± 0.17 (0.07–0.36) |
0.18 ± 0.07 (0.0–0.8) |
0.143 |
| Basophils (<0.21 × 109/L) |
0.06 ± 0.02 (0.01–0.09) |
0.11 ± 0.22 (0.0–0.08) |
0.248 | 0.06 ± 0.03 (0.0–0.12) |
0.06 ± 0.03 (0.0–0.8) |
0.481 |
| Sodium (137–147 × mmol/L) |
140 ± 2 (135–145) |
139 ± 2 (136–146) |
0.253 | 140 ± 3 (135–146) |
140 ± 2 (137–144) |
0.643 |
| Potassium (3.5–5.0 × mmol/L) |
4.5 ± 0.3 (3.5–5.0) |
4.3 ± 0.4 (3.6–5.4) |
0.120 | 4.4 ± 0.3 (3.8–5.0) |
4.4 ± 0.3 (4.0–4.8) |
0.687 |
| Chloride (96–109 × mmol/L) |
105 ± 2 (100–110) |
104 ± 2 (99–109) |
0.439 | 105 ± 2 (101–108) |
105 ± 3 (101–111) |
0.785 |
| Bicarbonate (25–33 × mmol/L) |
28 ± 2 (24–32) |
28 ± 2 (24–32) |
0.489 | 28 ± 2 (25–31) |
27 ± 2 (23–30) |
0.420 |
| Creatinine (40–110 × umol/L) |
74 ± 11 (51–93) |
74 ± 13 (52–93) |
0.911 | 75 ± 12 (47–95) |
71 ± 14 (44–95) |
0.419 |
| eGFR (>59 mL/min) |
81 ± 5 (59–90) |
76 ± 7 (65–90) |
0.400 | 81 ± 7 (66–89) |
78 ± 8 (63–90) |
0.305 |
| Urea (3.0–8.5 mmol/L) |
5.92 ± 1.35 (4.5–9.4) |
6.18 ± 1.73 (3.5–11.0) |
0.560 | 5.85 ± 1.59 (4.2–9.0) |
6.01 ± 1.37 (3.40–9.10) |
0.721 |
| Total Bilirubin (2–20 × umol/L) |
11 ± 6 (4–28) |
10 ± 4 (4–20) |
0.415 | 12 ± 7 (5–36) |
10 ± 4 (4–19) |
0.125 |
| Alk Phosphatase (ALP) (30–115 × U/L) |
73 ± 18 (36–107) |
78 ± 18 (43–115) |
0.368 | 71 ± 18 (31–112) |
75 ± 19 (37–108) |
0.506 |
| Gamma-glutamyl transferase (GGT) (0–45 U/L) |
37 ± 23 (11–119) |
49 ± 51 (10–262) |
0.313 | 33 ± 16 (10–68) |
43 ± 44 (14–208) |
0.303 |
| Alanine aminotransferase (ALT) (0–45 U/L) |
40 ± 21 (17–110) |
35 ± 16 (16–74) |
0.437 | 36 ± 14 (13–68) |
29 ± 12 (14–57) |
0.083 |
| Aspartate aminotransferase (AST) (0–41 U/L) |
30 ± 9 (18–66) |
26 ± 7 (15–40) |
0.117 | 30 ± 8 (19–45) |
23 ± 7 (12–40) |
0.007 ^ |
| Lactate Dehydrogenase (LD) (120–250 U/L) |
199 ± 31 (159–269) |
183 ± 32 (114–227) |
0.081 | 195 ± 25 (161–254) |
170 ± 23 (100–200) |
0.001 ^ |
| Calcium (2.25–2.65 × mmol/L) |
2.37 ± 0.065 (2.26–2.53) |
2.34 ± 0.09 (2.15–2.51) |
0.140 | 2.37 ± 0.07 (2.18–2.48) |
2.34 ± 0.07 (2.23–2.49) |
0.218 |
| Phosphate (0.8–1.5 × mmol/L) |
1.14 ± 0.16 (0.7–1.4) |
1.09 ± 0.20 (0.8–1.5) |
0.358 | 1.11 ± 0.14 (0.8–1.3) |
1.17 ± 0.22 (0.7–1.5) |
0.252 |
| Total Protein (60–82 × g/L) |
71 ± 4 (64–79) |
70 ± 4 (66–78) |
0.632 | 70 ± 3 (62–76) |
69 ± 3 (63–76) |
0.128 |
| Albumin (35–50 × g/L) |
42 ± 2 (39–47) |
42 ± 2 (38–47) |
0.640 | 42 ± 2 (38–47) |
42 ± 2 (37–45) |
0.439 |
| Globulin (20–40 × g/L) |
28 ± 5 (21–36) |
28 ± 3 (23–32) |
0.634 | 28 ± 3 (20–34) |
26 ± 5 (5–31) |
0.144 |
n = 25 active group, n = 23 placebo group. * Numbers in brackets are healthy reference ranges. # Data written as mean ± SD with range (in brackets). ^ AST and LD levels, whilst significantly different, were all within Healthy Reference Range, so unlikely to be clinically significant.