Daily v. weekly oral vitamin D3 therapy for nutritional rickets in Indian children: a randomised controlled open-label trial

The aim of the study was to compare the efficacy of daily v. weekly oral vitamin D-3 therapy in radiological healing of nutritional rickets. Children 6 months to 12 years (n 132) diagnosed with nutritional rickets were randomised into three groups (n 44): group A - 2000 IU daily vitamin D-3 for 12 weeks, B - 60 000 IU weekly for 3 weeks, C - 60 000 IU weekly for 6 weeks. Serum calcium, phosphorus, 25-hydroxyvitamin D (25(OH)D), parathyroid hormone and X-ray score were estimated at baseline and 12 weeks (endline). The proportion of children who achieved complete radiological healing at endline was compared between three groups by chi (2) and delta change in laboratory parameters by ANOVA (parametric data) or Kruskal Wallis test (non-parametric data), respectively. Baseline 25(OH)D <= 20 ng/ml was seen in 119 (90 center dot 2 %), hyperparathyroidism in 90 (68 center dot 8 %) and hypocalcaemia in 96 (72 center dot 7 %). A total of 120/132 children completed the study. Complete radiological healing seen in 30 (75 %) in group A, 23 (60 center dot 5 %) in group B and 26 (61 center dot 9 %) in group C; P = 0 center dot 15, with comparable endline X-ray scores; P = 0 center dot 31. The median (interquartile range (IQR)) delta X-ray score (baseline-endline) was 7 (4,9), 5 (2 center dot 25, 6) and 6 (4,7) in groups A, B and C, respectively; P = 0 center dot 019. Median (IQR) 25(OH)D endline levels in groups A, B and C were 50 center dot 0 (26 center dot 5, 66 center dot 5), 42 center dot 1 (28 center dot 4, 54 center dot 4) and 53 center dot 5 (33 center dot 7, 71 center dot 2) ng/ml, respectively; P = 0 center dot 045. Radiological scores were comparable at endline among daily and weekly vitamin D groups with greater change from baseline in daily supplemented group.