IMPE Abstracts

Objective: Compare the efficacy and safety of daily vs fortnightly oral vitamin D3 in treating symptomatic vitamin D deficiency in children aged 1-10 years.

Methods: 80 children with symptomatic vitamin D deficiency and serum 25(OH)D ≤20 ng/ml were randomized into group A and group B to receive oral vitamin D3 daily (4000 IU/day) for 12 weeks or 60000 IU fortnightly for total six doses over three months respectively. Both groups received daily oral calcium of @50 mg/kg/day. Serum calcium (Ca), phosphate (P), alkaline phosphatase (ALP), 25-hydroxy cholecalciferol (25(OH)D), parathyroid hormone (PTH) levels, urine calcium: creatinine ratio, and radiological score were assessed at baseline, 4 and 12 weeks. At the end of 12 weeks, 74 children were available for evaluation. The efficacy of both regimens was evaluated by comparing the proportion of children with normalization of biochemical parameters and radiological scores. The safety of therapy was estimated by measuring the frequency of hypercalcemia, hypercalciuria, and hypervitaminosis D.

Results: Both regimens led to a statistically significant increase in serum Ca and P levels and a statistically significant fall in serum ALP and PTH levels from baseline to 4 and 12 weeks of therapy, with no inter-group difference at any point of assessment. Though insignificant, subjects in group D had higher median 25(OH)D levels as compared to group B at both four weeks (group D 32.45(21.70- 36.03) ng/mL, group B 26.78(19.83-44.20) ng/mL; p - 0.60) and 12 weeks (group D 69.90(46.96- 91.90) ng/mL, group B 62.70(46.87-82.70) ng/mL; p- 0.30). 8 children had hypercalciuria before initiation of therapy while 17 other children developed hypercalciuria after starting treatment. None of them had hypervitaminosis D or nephrocalcinosis.

Conclusions: Both daily and fortnightly oral vitamin D3 in equivalent doses are equally efficacious and safe for treating symptomatic vitamin D deficiency in children 1-10 years.

Key words: Vitamin D, 25(OH)vitamin D, hypercalciuria, rickets.