Table 3 Intention-to-treat (ITT) and per protocol (PP) analysis of biochemical parameters.

From: Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial)

Variables At 78 weeks p value Overall Effect Size (95 %CI)
Intervention Placebo
FBG (mg/dl) ITT 101.8 ± 11.9 106.9 ± 26.9 0.04 −5.0 (−12.6, 2.4)
PP 107.4 ± 22.0 111.7 ± 30.7 0.46 −4.3 (−16.2, 7.5)
Haemoglobin A1c (%) ITT 5.80 ± 1.05 6.21 ± 1.45 0.05 −0.41 (5.89, 6.51)
PP 6.2 ± 1.21 6.18 ± 1.10 0.45 −0.03 (5.93, 6.46)
2-h blood glucose post OGTT (mg/dl) ITT 138.4 ± 55.1 149.5 ± 61.9 0.02 −11.1 (−49.3, 26.9)
PP 168.4 ± 81.6 162.6 ± 82.5 0.75 5.8 (−30.5, 42.1)
25(OH) D (nmol/l) ITT 56.6 ± 12.6 49.1 ± 12.1 0.002 7.5 (−6.0, 20.9)
PP 56.8 ± 32.1 48.7 ± 32.4 0.26 8.08 (−6.2, 22.3)
PTH (pg/ml) ITT 37.9 ± 20.2 41.9 ± 23.8 0.05 −3.9 (−11.9, 3.9)
PP 39.9 ± 18.2 40.8 ± 18.4 0.8 −0.89 (−8.9, 7.2)
Calcium (mg/dL) ITT 9.3 ± 0.7 9.3 ± 0.7 0.98 −0.002 (−0.3, 0.3)
PP 9.2 ± 0.3 9.2 ± 0.4 0.64 0.03 (−0.1, 0.2)
Phosphorus (mg/dL) ITT 3.78 ± 0.5 3.89 ± 0.6 0.26 −0.10 (−0.3, 0.1)
PP 3.8 ± 0.5 3.7 ± 0.4 0.5 0.069 (−0.2, 0.3)
Fasting insulin (μg/ml) ITT 10.6 ± 4.8 10.1 ± 4.7 0.61 0.4 (−1.3, 2.2)
PP 8.9 ± 4.0 9.1 ± 4.1 0.8 −0.14 (−1.9, 1.6)
HOMA-IR ITT 1.20 ± 0.06 1.24 ± 0.04 0.09 −1.26 (−2.8, 0.3)
PP 1.18 ± 0.04 1.19 ± 0.05 0.1 −1.18 (−2.4, 0.29)
  1. ITT, Intention-to-treat (n, 61 for intervention group and n, 60 for placebo group); PP, per protocol (n, 41 for intervention group and n, 41 for placebo group); FBG, fasting blood glucose; OGTT, Oral glucose tolerance test; 25(OH) D, 25-hydroxy vitamin D; PTH, Parathyroid hormone; HOMA-IR, Homeostatic Model Assessment of Insulin Resistance. Values are expressed as mean  ± SD. p value < 0.05 is statistically significant.