Daily versus fortnightly oral vitamin D₃ in treatment of symptomatic vitamin D deficiency in children aged 1−10 years: An open labelled randomized controlled trial

Objective Compare the efficacy and safety of daily versus fortnightly oral vitamin D 3 in treating symptomatic vitamin D deficiency in children aged 1−10 years. Design Open labelled randomized controlled trial. Patients Eighty children with symptomatic vitamin D deficiency were randomized into group daily (D) and group bolus (B) [40 in each group] to receive oral vitamin D 3 , 4000 IU daily or 60,000 IU fortnightly for 12 weeks respectively. Both groups received daily oral calcium of 500 mg/day. Measurements 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 weeks and 12 weeks. At the end of 12 weeks, 74 children were available for evaluation of the efficacy and safety of both regimens. Results Both regimens led to a significant increase in Ca and P levels and a fall in ALP and PTH levels from baseline to 4 and 12 weeks of therapy, with no intergroup difference. At 4‐ and 12‐week assessments, all children in both treatment arms achieved 25(OH)D level in sufficiency range, with no significant difference in their geometric mean. Both regimens were associated with asymptomatic transient hypercalcemia [group D—51.4% vs. group B—34.3%; p −0.14] and hypercalciuria (5.7%) in group D that resolved spontaneously on follow‐up. Conclusions Daily and fortnightly oral vitamin D 3 in similar cumulative doses are efficacious for treating symptomatic vitamin D deficiency in children (1−10 years). Treated children should be monitored for serum 25(OH)D, Ca and urinary calcium creatinine ratio.