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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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Nutrition Journal

ISSN: 1475-2891

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