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Table 9 Safety parameter assessment at baseline and day 180 in placebo, GC and UC-II groups

From: Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study

Parameter (Units)   Baseline Day 180
Normal range Placebo (n = 58) GC (n = 65) UC-II (n = 63) p value GC vs PBO p value UC-II vs PBO p value UC-II vs GC Placebo (n = 53) GC (n = 56) UC-II (n = 53) p value GC vs PBO p value UC-II vs PBO p value UC-II vs GC
Hematology  
Hemoglobin (gm/dL) 12.1–17.2 12.1 ± 0.22 11.9 ± 0.21 12.1 ± 0.20 0.7613 0.9948 0.8095 12.7 ± 0.24 12.4 ± 0.20 12.7 ± 0.18 0.4454 0.9727 0.5851
ESR (mm/h) 0–29 21.1 ± 1.77 23.9 ± 2.18 17.5 ± 1.56 0.7629 0.1034 0.0144 15.1 ± 1.24 17.0 ± 1.91 13.6 ± 1.28 0.9424 0.5364 0.3387
RBC (million/mm3) 4.7–6.1 4.29 ± 0.08 4.21 ± 0.08 4.33 ± 0.09 0.7747 0.9388 0.5498 4.32 ± 0.08 4.25 ± 0.08 4.37 ± 0.08 0.7935 0.8946 0.5129
WBC (/mm3) 4500-10,000 7979 ± 234 8248 ± 222 7795 ± 249 0.7020 0.8483 0.3523 7984 ± 204 7981 ± 209 7769 ± 204 1.0000 0.7706 0.7639
Platelet count (x100000/mm3) 1.5-4.5 2.77 ± 0.08 2.84 ± 0.08 2.78 ± 0.08 0.7837 0.9946 0.8319 2.77 ± 0.07 2.84 ± 0.07 2.77 ± 0.09 0.8304 0.9993 0.8113
Liver Function  
Albumin (gm/dL) 3.5–5.5 3.98 ± 0.06 4.02 ± 0.06 3.94 ± 0.06 0.8957 0.9089 0.6503 4.00 ± 0.05 4.03 ± 0.05 3.96 ± 0.04 0.8931 0.8902 0.6292
ALP (IU/L) 44–147 117 ± 5.74 118 ± 5.84 115 ± 5.57 0.9871 0.9838 0.9404 123 ± 5.72 116 ± 5.49 115 ± 5.59 0.5622 0.4847 0.9890
SGOT (U/L) 10–34 25.2 ± 0.93 24.0 ± 0.97 24.4 ± 0.60 0.5778 0.7796 0.9421 24.6 ± 0.73 23.9 ± 0.81 23.9 ± 0.65 0.7711 0.7930 0.9995
SGPT (U/L) 5–35 25.9 ± 1.23 25.0 ± 1.40 24.1 ± 0.95 0.5977 0.6004 1.0000 24.5 ± 0.94 24.3 ± 1.00 23.3 ± 0.99 0.9688 0.7119 0.8427
Total bilirubin (mg/dL) 0.3–1.9 0.78 ± 0.08 0.69 ± 0.03 0.72 ± 0.03 0.5376 0.9424 0.7343 0.72 ± 0.03 0.67 ± 0.03 0.78 ± 0.04 0.4243 0.6098 0.0718
Cardiac Function  
Systolic BP (mm Hg) <120 125 ± 1.28 127 ± 1.35 127 ± 1.21 0.5980 0.7320 0.9752 127 ± 1.18 125 ± 1.33 128 ± 1.22 0.7263 0.8949 0.4409
Diastolic BP (mm Hg) < 80 81.2 ± 1.19 80.2 ± 0.83 81.7 ± 1.02 0.7544 0.9283 0.5094 80.2 ± 1.03 80.5 ± 1.07 78.9 ± 0.96 0.9877 0.6233 0.5180
Pulse rate (beats/min) 60–100 80.0 ± 0.92 79.6 ± 0.98 80.3 ± 0.99 0.9149 0.9719 0.7956 80.0 ± 0.89 78.2 ± 0.82 79.2 ± 1.03 0.3201 0.8018 0.6989
Renal Function  
Creatinine (mg/dL) 0.6–1.3 1.00 ± 0.03 1.01 ± 0.04 0.96 ± 0.03 0.9995 0.5767 0.5778 0.96 ± 0.03 0.95 ± 0.02 0.96 ± 0.02 0.9904 0.9846 0.9508
BUN (mg/dL) 6–24 18.1 ± 1.08 18.0 ± 1.11 18.0 ± 1.15 0.9929 0.9878 0.9992 18.6 ± 1.11 17.8 ± 1.09 17.9 ± 1.02 0.7602 0.7953 0.9985
  1. Results are presented as Mean ± SE. Normal ranges were obtained from Medlinea and the Mayo Clinicb. Data was analyzed using ANCOVA followed by Tukey’s multiple comparisons test (p > 0.05)
  2. Abbreviations:
  3. ESR erythrocyte sedimentation rate; RBC red blood cell; WBC white blood cell; ALP alkaline phosphatase; SGOT serum glutamic oxaloacetic transaminase; SGPT serum glutamic pyruvic transaminase; BP blood pressure; BUN blood urea nitrogen
  4. aADAM, Inc.: http://www.nlm.nih.gov/medlineplus/encyclopedia.html (accessed October 2015)
  5. bMayo Foundation for Medical Education and Research: Mayo Clinic. www.mayoclinic.org (accessed October 2015)
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