Table 2

Change in Primary and Secondary Outcome Variables in VINDICATE at 12 Months Post-Randomization: Intention-to-Treat Population

EndpointRandomized TreatmentMean Change After 12 MonthsANCOVA
Difference in Mean Change
p Value
Primary outcome
 6-min walk distance, mPlacebo10.10 (-20.77 to 40.96)-24.11 (-65.81 to 17.60)0.255
Vitamin D-12.56 (-40.80 to 15.68)
Secondary outcomes
 LVEF, %Placebo1.36 (-0.38 to 3.11)6.07 (3.20 to 8.94)<0.001
Vitamin D7.65 (5.21 to 10.09)
 LVEDD, mmPlacebo-0.08 (-1.25 to 1.10)-2.49 (-4.09 to -0.90)0.002
Vitamin D-2.45 (-3.70 to -1.21)
 LVESD, mmPlacebo-0.99 (-2.31 to 0.33)-2.09 (-4.11 to -0.06)0.043
Vitamin D-2.72 (-4.52 to -0.92)
 LVEDV, mlPlacebo-3.83 (-13.36 to 5.70)-13.11 (-25.63 to -0.60)0.040
Vitamin D-16.47 (-25.71 to -7.22)
 LVESV, mlPlacebo-8.49 (-17.98 to 1.01)-12.65 (-24.76 to -0.54)0.041
Vitamin D-18.77 (-25.96 to -9.59)

Values are mean change (95% confidence intervals); 95% significance shown in bold.

ANCOVA = analysis of covariance; other abbreviations as in Table 1.