Daily vitamin D3 in overweight and obese children and adolescents: a randomized controlled trial.

To assess the efficacy of different doses of vitamin D3 on serum 25-hydroxyvitamin D (25(OH)D), intact parathyroid hormone(iPTH), calcium, phosphorus, and alkaline phosphatase concentrations in overweight and obese school-children. A total of 378 children and adolescents, 6–13 years of age, with age- and sex-specific body mass index(BMI) Z-score ≥ 1(according to the World Health Organization criteria) were allocated to receive 600, 1000, and 2000 IU vitamin D3/days. 25(OH)D, iPTH, calcium, phosphorus, and alkaline phosphatase concentrations were measured at baseline, 6, and 12 months. In this intention-to-treat analysis, we fitted a linear mixed effect model involving a random effect of participants within treatment groups and fixed effects of dose, time, and their interactions. Mean(SD) of age and BMI Z-score were 9.3 (1.7) years and 2.55 (0.73), respectively. The median (IQR) for 25(OH)D was 11.5 (8.9), 11.7 (10.5), 12.2 (10.2) ng/mL (28.75, 29.25, and 30.50 nmol/L) at baseline and 23.1 (8.0), 25.6 (8.3), 28.6 (10.4) ng/mL (57.75, 64.00, and 71.50 nmol/L) at the end of 12 months in 600, 1000, and 2000 IU, respectively (p values for dose, time, and the interaction being < 0.0001, < 0.0001,and 0.082, respectively). Prevalence of vitamin D deficiency (< 20 ng/mL) was 80.2, 77.5, and 75.5% in 600, 1000, and 2000 IU groups at baseline, respectively, which decreased to 34, 18.4, and 7.5%, respectively, at 12 months. Patterns of iPTH, calcium, phosphorus, and alkaline phosphatase response over time did not differ significantly among groups (p values = 0.452, 0.670, 0.377, 0.895, respectively). Increases in 25(OH)D concentration were found with supplementation of 1000 and 2000 IU, compared with 600 IU/days, whereas there was no evidence of iPTH suppression or change in serum calcium, phosphorus, and alkaline phosphatase among children with excess weight.