Table 2.
Baseline |
6-Months Follow-up |
Absolute Rx Effect** |
Relative Effect§ |
95% CI$ | Pinteraction¤ | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean | SE | P* | N | Mean | SE | P* | N | Mean | SE | P* | |||||
A. p21¥expression in colorectal crypts | ||||||||||||||||
Entirecrypts (LI) | ||||||||||||||||
Placebo | 22 | 1.23 | 0.17 | 21 | 1.00 | 0.18 | 20 | 0.00 | 1.00 | |||||||
Calcium | 23 | 0.85 | 0.17 | 0.11 | 21 | 1.37 | 0.18 | 0.14 | 21 | 0.78 | 0.33 | 0.03 | 2.01 | 1.08 | 3.72 | |
Vitamin D | 22 | 0.81 | 0.17 | 0.08 | 21 | 1.58 | 0.18 | 0.02 | 20 | 0.98 | 0.34 | 0.01 | 2.42 | 1.30 | 4.51 | |
Ca + Vit. D | 23 | 1.12 | 0.17 | 0.62 | 21 | 1.13 | 0.18 | 0.60 | 21 | 0.23 | 0.33 | 0.47 | 1.25 | 0.69 | 2.26 | 0.01 |
Upper 40% of crypts (LI40) | ||||||||||||||||
Placebo | 22 | 1.10 | 0.15 | 21 | 0.91 | 0.16 | 20 | 0.00 | 1.00 | |||||||
Calcium | 23 | 0.86 | 0.15 | 0.26 | 21 | 1.43 | 0.16 | 0.02 | 21 | 0.77 | 0.31 | 0.02 | 2.02 | 1.11 | 3.66 | |
Vitamin D | 22 | 0.77 | 0.15 | 0.13 | 21 | 1.54 | 0.16 | 0.01 | 20 | 0.96 | 0.31 | 0.00 | 2.44 | 1.31 | 4.53 | |
Ca + Vit. D | 23 | 1.02 | 0.15 | 0.70 | 21 | 1.09 | 0.16 | 0.43 | 21 | 0.26 | 0.31 | 0.41 | 1.29 | 0.71 | 2.34 | 0.004 |
B. MIB-1¥expression in colorectal crypts | ||||||||||||||||
Entire crypts (LI) | ||||||||||||||||
Placebo | 22 | 1.01 | 0.10 | 21 | 1.00 | 0.10 | 20 | 0.00 | 1.00 | |||||||
Calcium | 23 | 0.90 | 0.09 | 0.42 | 21 | 1.09 | 0.10 | 0.50 | 21 | 0.18 | 0.19 | 0.30 | 1.23 | 0.84 | 1.80 | |
Vitamin D | 22 | 0.83 | 0.10 | 0.18 | 22 | 1.08 | 0.10 | 0.58 | 22 | 0.25 | 0.19 | 0.18 | 1.32 | 0.89 | 1.96 | |
Ca + Vit. D | 23 | 1.25 | 0.09 | 0.09 | 21 | 1.10 | 0.10 | 0.49 | 21 | −0.13 | 0.19 | 0.50 | 0.89 | 0.62 | 1.27 | 0.04 |
Ratio of upper 40% to entire crypts (φh) | ||||||||||||||||
Placebo | 22 | 0.07 | 0.01 | 21 | 0.06 | 0.01 | 20 | 0.00 | 1.00 | |||||||
Calcium | 23 | 0.09 | 0.01 | 0.40 | 21 | 0.07 | 0.01 | 0.64 | 21 | −0.01 | 0.03 | 0.80 | 0.94 | 0.47 | 1.87 | |
Vitamin D | 22 | 0.08 | 0.01 | 0.56 | 22 | 0.07 | 0.01 | 0.71 | 22 | −0.003 | 0.03 | 0.89 | 0.97 | 0.48 | 1.94 | |
Ca + Vit. D | 23 | 0.08 | 0.01 | 0.72 | 21 | 0.07 | 0.01 | 0.84 | 21 | −0.003 | 0.03 | 0.92 | 0.97 | 0.48 | 1.97 | 0.68 |
C. hTERT¥expression in colorectal crypts | ||||||||||||||||
Entire crypts (LI) | ||||||||||||||||
Placebo | 21 | 1.08 | 0.10 | 20 | 1.00 | 0.10 | 19 | 0.00 | 1.00 | |||||||
Calcium | 22 | 1.01 | 0.10 | 0.63 | 20 | 1.00 | 0.10 | 0.99 | 19 | 0.07 | 0.21 | 0.73 | 1.07 | 0.72 | 1.59 | |
Vitamin D | 22 | 0.83 | 0.10 | 0.08 | 22 | 0.97 | 0.10 | 0.85 | 21 | 0.25 | 0.21 | 0.27 | 1.27 | 0.84 | 1.93 | |
Ca + Vit. D | 22 | 1.08 | 0.10 | 0.98 | 21 | 1.06 | 0.10 | 0.70 | 20 | 0.14 | 0.21 | 0.80 | 1.05 | 0.72 | 1.54 | 0.33 |
Ratio of upper 40% to entire crypts (φh) | ||||||||||||||||
Placebo | 21 | 0.37 | 0.01 | 20 | 0.42 | 0.01 | 19 | 0.00 | 1.00 | |||||||
Calcium | 22 | 0.39 | 0.01 | 0.33 | 20 | 0.39 | 0.01 | 0.24 | 19 | −0.04 | 0.03 | 0.13 | 0.90 | 0.78 | 1.03 | |
Vitamin D | 22 | 0.37 | 0.01 | 0.81 | 22 | 0.41 | 0.01 | 0.63 | 21 | −0.01 | 0.03 | 0.61 | 0.97 | 0.85 | 1.11 | |
Ca + Vit. D | 22 | 0.39 | 0.01 | 0.25 | 21 | 0.37 | 0.01 | 0.03 | 20 | −0.07 | 0.03 | 0.02 | 0.85 | 0.74 | 0.98 | 0.93 |
P-value for difference between each active treatment group and placebo group from Mixed model. Covariates included random intercept, follow-up visit, treatment group, and treatment group by follow-up visit interaction.
Absolute treatment effect = ([treatment group follow-up - treatment group baseline] - [placebo group follow-up - placebo group baseline]); actual calculations from the Mixed model, in which the interactions between treatment group and follow-up visits terms estimate absolute treatment effect in each active treatment group relative to the placebo.
Relative effect = [(treatment group follow-up/treatment group baseline)/(placebo follow-up/placebo baseline)]; interpretation similar to that for an odds ratio (e.g., a relative effect of 1.8 would indicate a proportional increase of 80% in the treatment group relative to that in the placebo group).
95% confidence interval for relative effect calculated by the Delta method (24).
P-value for interaction between calcium and vitamin D3 treatments from Mixed model; covariates included random intercept, two factors (calcium and vitamin D3 coded as 0/1 variable), follow-up visit, and all appropriate interaction terms between factors and follow-up visit.
Biomarkers detected immunohistochemically and then their labeling densities were quantified by image analysis; all biomarkers values shown as batch-standardized optical densities. Batch standardization for each biomarker was performed by dividing each individual measurement by the staining batch’s average optical density.