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

To compare the efficacy and safety of 300,000 and 600,000 IU 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 15 ng/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.