Table 4. Hematology and clinical chemistry analysis at the baseline and week 12 for the 85 subjects in the safety population.
| Safety parameters | Time points | CTP20 group | Placebo group | ||
|---|---|---|---|---|---|
| Mean ± SD | P-value | Mean ± SD | P-value | ||
| Albumin (g/dL) | Baseline | 4.486 ± 0.257 | 0.438 | 4.476 ± 0.213 | 0.893 |
| At 12 weeks | 4.502 ± 0.235 | 4.485 ± 0.165 | |||
| Hemoglobin (g/dL) | Baseline | 12.702 ± 1.527 | 0.049* | 13.161 ± 1.024 | 0.001** |
| At 12 weeks | 12.577 ± 1.249 | 12.902 ± 1.061 | |||
| Hematocrit (%) | Baseline | 39.725 ± 4.024 | 0.697 | 40.385 ± 2.700 | 0.245 |
| At 12 weeks | 39.741 ± 3.312 | 40.076 ± 2.826 | |||
| Platelet (103/μL) | Baseline | 277.477 ± 65.922 | 0.347 | 260.415 ± 75.091 | 0.023* |
| At 12 weeks | 282.773 ± 61.753 | 271.463 ± 73.819 | |||
| Red blood cell (106/μL) | Baseline | 4.346 ± 0.302 | 0.116 | 4.275 ± 0.285 | 0.099 |
| At 12 weeks | 4.288 ± 0.269 | 4.225 ± 0.290 | |||
| White blood cell (103/μL) | Baseline | 5.625 ± 1.501 | 0.062 | 5.041 ± 1.282 | 0.256 |
| At 12 weeks | 5.275 ± 1.261 | 5.429 ± 2.477 | |||
| Mean cell volume (fL) | Baseline | 91.355 ± 6.533 | < 0.001*** | 94.532 ± 3.644 | 0.137 |
| At 12 weeks | 92.745 ± 6.317 | 94.946 ± 4.529 | |||
| Glucose (mg/dL) | Baseline | 88.159 ± 8.944 | 0.226 | 84.512 ± 8.964 | 0.060 |
| At 12 weeks | 89.568 ± 11.182 | 87.268 ± 9.628 | |||
| ALT (U/L) | Baseline | 15.114 ± 5.537 | 0.259 | 13.610 ± 5.176 | 0.680 |
| At 12 weeks | 14.182 ± 6.431 | 14.659 ± 7.647 | |||
| AST (U/L) | Baseline | 18.955 ± 4.046 | 0.190 | 18.927 ± 4.782 | 0.341 |
| At 12 weeks | 18.182 ± 3.611 | 20.366 ± 8.587 | |||
| Total bilirubin (mg/dL) | Baseline | 0.410 ± 0.171 | 0.522 | 0.550 ± 0.335 | 0.545 |
| At 12 weeks | 0.425 ± 0.167 | 0.515 ± 0.545 | |||
| Urinary (pH) | Baseline | 6.045 ± 0.933 | 0.064 | 6.000 ± 0.859 | 0.434 |
| At 12 weeks | 6.284 ± 0.167 | 5.915 ± 0.749 | |||
| Creatinine (mg/dL) | Baseline | 0.603 ± 0.082 | 0.538 | 0.645 ± 0.075 | 0.959 |
| At 12 weeks | 0.608 ± 1.008 | 0.646 ± 0.090 | |||
| Urine specific gravity | Baseline | 1.019 ± 0.006 | 0.042* | 1.021 ± 0.005 | 0.157 |
| At 12 weeks | 1.021 ± 0.008 | 1.022 ± 0.007 | |||
Hydrolyzed fish collagen (Collagen-Tripep20™, Tripep20) was prepared from Pangasius hypophthalmus fish skin by collagenase digestion. Liquid collagen (1,000 mg Tripep20) or placebo in a 50 mL bottle was administered orally to all subjects as a daily drink. P-value for a paired t-test or Wilcoxon signed-rank test compared to the baseline. The normality was assessed using a Kolmogorov-Smirnov test, and the homogeneity was examined using an independent t-test and Mann-Whitney U test.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.