Table 2 Changes in serum biomarker levels: intention-to-treat analysis.

From: Effects of personalized vitamin D3 on inflammation in colorectal cancer patients: a randomized trial

  

Biomarker (NPX mean values)

  

IL-6

INF-γ

MMP-1

Placebo (n = 65)

BL

3.45 (1.25)

7.96 (1.35)

15.24 (0.96)

FU2

3.18 (1.40)

7.63 (1.44)

15.11 (0.95)

Within-study-arm mean difference (95% CI)

−0.22 (−0.61, 0.18)

−0.23 (−0.56, 0.10)

−0.10 (−0.18, −0.01)

Percentage actual change from BL to FU2 (95% CI)1

−14.1 (−34.5, 13.3)

−14.7 (−32.2, 7.2)

−6.7 (−11.7, −0.69)

p valuea

0.276

0.166

0.031

Intervention (n = 61)

BL

3.47 (1.26)

7.96 (1.32)

15.36 (0.59)

FU2

2.59 (0.86)

7.48 (0.94)

15.19 (0.50)

Within-study-arm mean difference (95% CI)

−0.80 (−1.16, −0.45)

−0.40 (−0.72, −0.09)

−0.18 (−0.27, −0.10)

Percentage actual change from BL to FU2 (95% CI)1

−42.6 (−55.2, −26.8)

−24.2 (−39.3, −6.0)

−11.7 (−17.1, −6.7)

p valuea

<0.001

0.013

<0.001

End of trial predicted changes (Intervention vs. Placebo group)b

 Model 1 (Unadjusted)

β−coefficient (95% CI)

−0.59 (−1.01, −0.18)

−0.15 (−0.59, 0.28)

0.09 (−0.19, 0.36)

Percentage actual change from BL to FU2 (95% CI)2

−33.6 (−50.3, −11.7)

−9.9 (−33.6, 21.4)

6.4 (−12.3, 28.3)

p−value

0.005

0.479

0.535

 Model 2 (Adjusted)

β−coefficient (95% CI)

−0.72 (−1.15, −0.29)

−0.10 (−0.52, 0.35)

−0.08 (−0.20, 0.05)

Percentage actual change from BL to FU2 (95% CI)2

−39.3 (−54.9, −18.2)

−6.7 (−30.3, 27.5)

−5.4 (−12.9, 3.5)

p value

0.001

0.692

0.227

  1. Serum biomarker values are in NPX values. For baseline and follow−up biomarker concentrations, mean values are presented with their respective standard deviations in parentheses. Mean changes are presented with their respective 95% confidence intervals. Bold figures are statistically significant after adjustment for family-wise error rate (FWER) using Bonferroni correction with an α-threshold of 0.0166.
  2. BL baseline, CI confidence interval, FU2 end of trial, IFN-γ interferon−gamma, IL-6 interleukin-6, MMP-1 matrix metalloproteinase-1, NPX normalized protein expression.
  3. ap values based on paired t-tests.
  4. bBased on linear regression models estimating biomarker changes in the intervention group versus placebo group (reference); Unadjusted biomarker changes were based on univariable model 1; Adjusted biomarker changes were based on multivariable model 2 controlled for baseline concentration of the respective inflammatory biomarker (continuous), baseline age (continuous), sex, baseline serum 25(OH)D (continuous), BMI (continuous), cancer stage (I, II, III, or IV), time since surgery (No surgery, 0−1, 2−3, 4−6, 7−9, 10−12, >12 months), previous chemotherapy and previous radiotherapy.
  5. 1Calculated from the formula (2Mean NPX Difference − 1) × 100%.
  6. 2Calculated from the formula (2β − 1) × 100%.
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