|
Variable
|
Trial Arms
|
Baseline
|
Midpoint
|
12 weeks
|
p- value midpoint vs BL
|
p-value 12wks vs midpoint
|
p-value 12wks vs BL
|
|---|
|
Lactate
|
KD
|
13.3 ± 11
|
10.8 ± 4
|
10.7 ± 3
|
1
|
1
|
1
|
|
Control
|
13.8 ± 4
|
14.7 ± 6
|
13.3 ± 4
|
0.94
|
0.93
|
1
|
|
MD (95% CI)
|
−0.51(−5.3,4.2)
|
−3.8 (−7,-0.7)
|
−2.6 (−4.8,-0.35)
|
1
|
0.01
|
0.02
|
|
LDH (u/l)
|
KD
|
680 ± 643
|
666 ± 770
|
535 ± 517
|
1
|
0.48
|
0.58
|
|
Control
|
706 ± 560
|
627 ± 556
|
472 ± 148
|
1
|
0.36
|
0.12
|
|
MD (95% CI)
|
−25 (− 374,323)
|
39 (− 330,409)
|
62 (− 145,271)
|
1
|
1
|
1
|
|
Ammonia (mcg/dl)
|
KD
|
58 ± 17
|
60 ± 17
|
66 ± 15
|
1
|
1
|
0.69
|
|
Control
|
75 ± 27
|
71 ± 36
|
75 ± 24
|
1
|
0.92
|
1
|
|
MD (95% CI)
|
−17 (−30,3.9)
|
−11(−29,6.9)
|
−9 (−20.8,2.4)
|
0.03
|
0.43
|
0.49
|
|
Albumin (g/dl)
|
KD
|
4.5 ± 0.33
|
4.5 ± 0.26
|
4.5 ± 0.33
|
1
|
1
|
1
|
|
Control
|
4.4 ± 0.43
|
4.5 ± 0.37
|
4.5 ± 0.37
|
1
|
1
|
1
|
|
MD (95% CI)
|
0.08(−0.13,0.29
|
0.04-(0.15,0.24)
|
0.04 (−0.16,0.2)
|
1
|
1
|
1
|
|
ALP
|
KD
|
197 ± 126
|
169 ± 76
|
149 ± 71
|
1
|
1
|
0.99
|
|
Control
|
325 ± 375
|
333 ± 440
|
240 ± 164
|
1
|
0.11
|
0.51
|
|
MD (95% CI)
|
− 127(− 285,29)
|
−164(−372,44)
|
−90(− 162,-19)
|
0.19
|
0. 13*
|
0.02*
|
|
K (meq/l)
|
KD
|
4.2 ± 0.39
|
4.1 ± 0.43
|
4.1 ± 0.33
|
1
|
0.46
|
0.13
|
|
Control
|
4.2 ± 0.35
|
4.3 ± 0.38
|
4.2 ± 0.37
|
1
|
1
|
0.75
|
|
MD95% CI
|
−0.05 (− 0.26,0.15)
|
−0.14)0.41,0.12(
|
−0.10 (−0.29,0.08)
|
1
|
0.69
|
0.88
|
|
P (mg/Dl)
|
KD
|
4 ± 0.71
|
3.9 ± 0.66
|
4.4 ± 0.88
|
1
|
0.05
|
0.06
|
|
Control
|
4.1 ± 0.92
|
4.2 ± 0.52
|
4.3 ± 0.65
|
1
|
1
|
1
|
|
MD95% CI
|
−0.17 (− 0.63,0.28(
|
−0.24 (0.63,0.14)
|
0.07 (−0.34,0.50(
|
1
|
0.93
|
1
|
|
Mg (mg/dL)
|
KD
|
2.1 ± 0.19
|
2 ± 0.13
|
2 ± 0.19
|
1
|
1
|
1
|
|
Control
|
2.1 ± 0.21
|
2 ± 0.19
|
2 ± 0.23
|
0.43
|
0.82
|
1
|
|
MD95% CI
|
−0.001 (− 0.11,0.11)
|
0.07 (− 0.03,0.18)
|
−0.02 (−0.14,0.09)
|
1
|
0.76
|
1
|
|
Ca (mg/dl)
|
KD
|
9.4 ± 1.2
|
9.4 ± 0.80
|
9.3 ± 0.59
|
0.37
|
1
|
0.16
|
|
Control
|
9/4 ± 0.95
|
9.2 ± 0.78
|
9.4 ± 0.56
|
0.84
|
0.85
|
1
|
|
MD95% CI
|
0.36
|
0.21
|
−0/10
|
0.42
|
1
|
1
|
|
Na (meq/l)
|
KD
|
146 ± 43
|
140 ± 3
|
140 ± 2
|
0.83
|
1
|
0.79
|
|
Control
|
138 ± 2.8
|
138 ± 2
|
133 ± 24
|
1
|
0.80
|
0.80
|
|
MD 95% CI
|
7.9(−9.8,25.7)
|
1.9 (0.19,3.6)
|
7 (−2.3,17.3)
|
0.56
|
1
|
0.63
|
- BL Baseline, Midpoint: 1st follow-up or week 6, 12 weeks: 12 weeks or last follow-up, MD Mean Difference, CI Confidence Interval Analysis type: Repeated measure, all p values were calculated based on Bonferroni correction for multiple comparisons * Ancova: Adjusted for base line value and cancer type
