Table 3.

Statistical comparison of the changes for the primary and secondary endpoints between baseline vs. week 8 (Phase I: Vitamin D withdrawal period) and between week 8 vs. week 16 (Phase II: randomization to Paracalcitriol versus Cinacalcet). Data are presented as P values.

Variables	Phase I Comparison between Baseline –to- 8 weeks	Phase II Comparison between 8 weeks-to-16 weeks
		Unadjusted	Adjusted
Insulin Resistance Indices
GDR	0.7	0.9	0.86
HOMA-IR	0.1	0.4	0.74
QUICKI	0.04*	0.4	0.78
HOMA-adiponectin	0.24	0.25	0.53
Leptin-adiponectin-ratio	0.9	0.6	0.74
Biomarkers of Inflammation
IL-6	0.57	0.5	0.87
hsCRP	0.3	0.5	0.81
Adipocytokines
Adiponectin	0.5	0.3	0.08
Leptin	0.3	0.7	0.53
Mineral Metabolism parameters
Parathyroid hormone, pg,mL	0.02*	0.06	0.2
Calcium, mg/dL
Phosphorus, mg/dL

Comparison from baseline to 8 weeks: p values were calculated using Wilcoxon Signed Rank test to compare the changes in outcomes from baseline to week 8.

Comparison from 8 weeks to 16 weeks:

Unadjusted: p values were calculated using multivariable linear regression. Independent variables included: treatment assignment and corresponding outcomes measured at week 8.

Adjusted: p values were calculated using multivariable linear regression with independent variables including: treatment assignment and corresponding outcomes measured at week 8, and propensity score [propensity scores were estimated through binary logistic regression providing the predicted probability of being assigned into treatment group A as a function of other risk factors including age, truncal fat, IL6, pth and leptin]