Comparison of 300,000 and 600,000IU Oral Vitamin-D Bolus for Vitamin-D Deficiency in Young Children.

Abstract

To compare the efficacy and safety of 300,000 and 600,000IU vitamin-D single-oral dose for the treatment of vitamin-D deficiency (VDD) in young children (3 mo - 3 y). This double-blind randomized control trial (Clinical Trail Registration-CTRI/2012/05/002621) was conducted in the Pediatric out-patient department (OPD) at a tertiary-care referral hospital. Children (3 mo - 3 y) with clinical/radiological features suggestive of VDD were screened; those found to be having 25(OH)D below 15ng/ml and meeting inclusion and exclusion criteria's were enrolled after taking informed consent. They were randomized into two groups, one receiving 600,000 and other 300,000 IU vitamin-D orally stat (Stoss-therapy). Primary outcome measure was proportion of children developing hypercalcemia/and hypercalciuria at day 7-10 post-therapy. Secondary outcome measures were proportion of children with hypercalciuria at day 3-5, hypercalcemia/and hypercalciuria at day 25-30 and 25(OH)D sufficiency at day 25-30 post-therapy. Sixty children, 30 in each group were randomized to two study groups. Baseline variables were comparable in two groups. Primary outcome measure (proportion of children with hypercalcemia/and hypercalciuria at 7 - 10th d) were 18.5% (5/27) in 600,000 and 10.7% (3/28) in 300,000 IU group (P=0.47). Secondary outcome measures were - i) Proportion of children with hypercalciuria (3-5th d) were 18.5% (5/27) in 600,000 and 7% (2/28) in 300,000 group (P=0.25). ii) Proportion of children with hypercalcemia/and hypercalciuria (25-30th d) were 18.5% (5/27) in 600,000 and 11% (3/28) in 300,000 group (P=0.47). iii) All children in both groups had 25(OH)D levels in sufficiency range (25-30th d). With this sample size no significant difference in any of the group could be established. The superiority of 300,000 over 600,000 IU vitamin-D single-dose oral therapy for VDD in children (3 mo - 3 y) in terms of safety could not be established with this sample size, although the prevalence of hypercalcemia/and hypercalciuria was observed more with 600,000 IU group. Both the regimens were effective for treating VDD at 25-30th d post-therapy.