Table 4.

Changes in plasma CRP and inflammation z-score levels stratified by sex and NSAID use in colorectal adenoma patients

 Baseline6-mo follow-upAbsolute treatment effectaRelative treatment effectb
nMeanSDMeanSDMean95% CIPc
CRP, μg/mL
Women
 Placebo73.553.502.992.85N/AN/AN/A1.00
 Calcium71.784.512.075.660.32(−0.91 to 1.55)0.601.38
 Vitamin D61.523.320.981.89−0.27(−1.55 to 1.00)0.660.76
 Calcium + vitamin D72.654.132.374.06−0.06(−1.17 to 1.28)0.920.94
Men
 Placebo161.283.611.484.79N/AN/AN/A1.00
 Calcium160.902.980.793.51−0.28(−0.74 to 0.19)0.240.76
 Vitamin D161.342.700.992.04−0.45(−0.90 to −0.01)0.050.63
 Calcium + vitamin D161.652.422.142.740.11(−0.36 to 0.57)0.641.12
Non-NSAID usersd
 Placebo191.373.591.514.13N/AN/AN/A1.00
 Calcium201.133.801.074.470.22(−0.70 to 0.37)0.431.25
 Vitamin D201.552.641.021.90−0.53(−1.05 to −0.01)0.050.59
 Calcium + vitamin D162.192.833.052.82−0.17(−0.34 to 0.78)0.530.84
Inflammation z-scoree
Women
 Placebo72.153.912.323.94N/AN/AN/A1.00
 Calcium7−1.392.78−1.453.39−0.23(−1.91 to 1.44)0.770.79
 Vitamin D6−1.072.50−1.683.70−0.78(−2.52 to 0.96)0.360.46
 Calcium + vitamin D7−0.063.740.373.12−0.14(−1.54 to 1.81)0.870.87
Men
 Placebo16−0.721.94−0.123.05N/AN/AN/A1.00
 Calcium160.172.75−0.032.69−0.85(−2.09 to 0.39)0.180.42
 Vitamin D16−0.712.79−1.822.44−1.75(−2.95 to −0.55)0.010.17
 Calcium + vitamin D160.882.770.863.03−0.67(−1.91 to 0.57)0.290.51
Non-NSAID usersd
 Placebo19−0.102.840.203.19N/AN/AN/A1.00
 Calcium20−0.603.57−0.842.88−0.56(−1.57 to 0.46)0.280.57
 Vitamin D20−0.802.51−1.892.67−1.42(−2.41 to −0.45)0.010.42
 Calcium + vitamin D160.022.421.083.01−0.08(−1.14 to 0.98)0.890.92
  • aAbsolute treatment effect is the absolute change from baseline to follow-up in the treatment group minus the absolute change from baseline to follow-up in the placebo group from mixed model.

  • bRelative treatment effect is defined as: (treatment group follow-up/treatment group baseline)/(placebo follow-up/placebo baseline).

  • cP values for difference between each treatment group and the placebo group from mixed model.

  • dNSAID user status at baseline (NSAID use by treatment group did not change during the course of the trial).

  • eInflammation z-score: z-score of pro- and anti-inflammatory markers (CRP, IL6, IL-1β, TNF-α, IL-8, and IL-10) calculated by subtracting the mean and dividing by the SD (thus creating a mean of zero and SD of 1.0) for each participant's individual biomarker value at each visit and then summing the biomarker z-score values for each participant at each visit (IL-10 was included with a negative sign).