Table 3.
Study Population Comprehensive Metabolic Panel and Complete Blood Count with Differential (10 ppm [n=36], 32 ppm [n=24], Total Sample [n=60])
| Comprehensive Metabolic Panel and Complete Blood Cell Count with Differential |
10 ppm Mean Change [95% CI: min, max] (p value) |
32 ppm Mean Change [95% CI: min, max] (p value) |
Total Sample Mean Change [95% CI: min, max] (p value) |
|---|---|---|---|
| Sodium [mmol/L] | −0.1[−0.7, 0.6] (0.87) | 0.2 [−0.7, 1.0] (0.71) | 0.03 [−0.5, 0.6] (0.90) |
| Potassium [mmol/L] | −0.1[−0.3, 0.02] (0.10) | −0.03 [−0.2, 0.1] (0.74) | −0.08 [−0.2, 0.03] (0.13) |
| Chloride [mmol/L] | −0.4[−1.2, 0.3] (0.23) | 0.04[−1.1, 1.2] (0.94) | −0.3[−0.9, 0.4] (0.44) |
| Carbon Dioxide [mmol/L] | 0.5[−0.5, 1.6] (0.33) | −0.04[−1.1, 1.0] (0.94) | 0.3[−0.5, 1.1] (0.44) |
| BUN* [mg/dL] | −0.9[−1.7, −0.1] (0.03)** | 0.5 [−0.08, 1.8] (0.41) | −0.3 [−1.1, 0.4] (0.37) |
| Creatinine [mg/dL] | 0.01 [−0.02, 0.03] (0.60) | −0.02 [−0.04, 0.01] (0.21) | −0.003 [−0.02, 0.01] (0.74) |
| Glucose [mg/dL] | 3.6 [−1.6, 8.7] (0.17) | −0.7 [−4.2, 2.9] (0.71) | 1.9 [−1.5, 5.3] (0.28) |
| ALP [U/L] | −1.4 [−3.9, 1.1] (0.28) | 2.0 [−1.0, 5.0] (0.18) | −0.03 [−2.0, 1.9] (0.97) |
| AST [U/L] | −0.44 [−2.1, 1.2] (0.60) | 2.0 [−2.6, 6.5] (0.40) | 0.5 [−1.5, 2.5] (0.61) |
| ALT [U/L] | −2.6 [−4.8, −0.3] (0.03)** | 2.3 (−1.6, 6.3) (0.25) | −0.6 (−2.7, 1.5) (0.58) |
| Total Protein [g/dL] | −0.02 [−0.3, 0.2] (0.87) | 0.2 [−0.001, 0.4] (0.051) | 0.1 [−0.1, 0.3] (0.45) |
| Total Bilirubin [mg/dL] | −0.02 [−0.08, 0.3] (0.43) | −0.03 [−0.11, 0.05] (0.49) | −0.02 [−0.07, 0.02] (0.29) |
| Albumin [g/dL] | −0.07 [−0.1, 0.0004) (0.06) | 0.11 [−0.01, 0.23] (0.09) | 0.002 [−0.07, 0.07] (0.96) |
| Calcium [mg/dL] | −0.1 [−0.2, 0.04] (0.20) | 0.1 [−0.003, 0.2] (0.06) | 0.0 [−0.1, 0.1] (0.99) |
| WBC Count [k/μL] | −0.17 [−0.53, 0.19] (0.35) | −0.09 [−0.68, 0.49] (0.75) | −0.14 [−0.46, 0.17] (0.38) |
| RBC Count [M/μL] | −0.08 [−0.17, −0.001] (0.047)** |
0.06 [−0.03, 0.14] (0.23) | −0.03 [−0.09, 0.03] (0.37) |
| Hemoglobin [gm/dL] | −0.2 [−0.4, 0.03] (0.08) | 0.1 [−0.2, 0.4] (0.41) | −0.1 [−0.3, 0.1] (0.41) |
| Hematocrit [%] | −0.7 [−1.5, 0.07] (0.075) | 0.8 [−0.1, 1.7] (0.095) | −0.1 [−0.8, 0.5] (0.68) |
| MCV [fL] | 0.1 [−0.6, 0.8] (0.80) | 0.5 [−0.1, 1.2] (0.12) | 0.3 [−0.2, 0.7] (0.29) |
| MCH [pg] | 0.1 [−0.1, 0.3] (0.48) | −0.1 [−0.4, 0.2] (0.38) | −0.01 [−0.2, 0.2] (0.96) |
| MCHC [gm/dL] | 0.1 [−0.3, 0.4] (0.72) | −0.3 [−0.7, 0.1] (0.12) | −0.1 [−0.3, 0.2] (0.53) |
| Platelets [k/μL] | 5 [−6, 15] (0.39) | −4 [−16, 8] (0.53) | 1.3 [−6.8, 9.4] (0.76) |
| Granulocytes [%] | −0.9 [−3.0, 1.1] (0.36) | −0.7 [−4.0, 2.7] (0.70) | −0.9 [−2.8, 1.0] (0.36) |
| Lymphocytes [%] | 0.7 [−1.2, 2.6] (0.46) | 1.3 [−1.5, 4.1] (0.36) | 1.0 [−0.8, 2.7] (0.27) |
| Monocytes [%] | −0.1 [−0.6, 0.4] (0.70) | −0.3 [−0.8, 0.3] (0.34) | −0.2 [−0.5, 0.2] (0.38) |
| Basophils [%] | 0.04 [−0.1, 0.2] (0.58) | 0.001 [−0.1, 0.1] (0.99) | −0.02 [−0.1, 0.1] (0.61) |
| Eosinophils [%] | −0.06 [−0.3, 0.2] (0.69) | −0.2 [−0.7, 0.2] (0.36) | −0.1 [−0.4, 0.1] (0.35) |
*
BUN- Blood Urea Nitrogen; ALP: Alkaline Phosphatase; AST: Aspartate Aminotransferase; ALT: Alanine Aminotransferase; WBC: White Blood Cells; RBC: Red Blood Cells; MCV: Mean Corpuscular Volume; MCH: Mean Corpuscular Hemoglobin; MCHC: Mean Corpuscular Hemoglobin Concentration.
**
p≤0.05 Comparison of 10 ppm or 32 ppm active solution vs. placebo solution, controlling for baseline value, in a mixed effects linear regression model.