6005 Comparing the efficacy & safety of single oral bolus dose of Vit D (50,000 IU) at birth to daily Vit D supplementation (400IU/Day) in healthy term infants

Objectives Primary objective : To compare efficacy and safety of single oral bolus dose (50,000IU) of Vitamin D at birth in healthy term babies to standard daily oral vitamin D (400 IU/day) supplementation during the first 4 months after birth. Secondary objectives : i) To find the prevalence of vitamin D deficiency (VDD) at birth in healthy term neonates ii) To assess the correlation of Vitamin D levels at birth to maternal vitamin D status and iii) To study the effect of bolus dose of Vitamin D on biochemical parameters of calcium homeostasis (calcium, phosphorus, alkaline phosphatase and vitamin D) at 1 month and 4 months of age. Methods This is a single-center, prospective open label, randomized, comparative study conducted from August 2017 to June 2018 in a tertiary care hospital in India. The clinical trial compared the efficacy and safety of standard oral daily dose (400 IU) to a single oral bolus dose (50000 IU) of vitamin D soon after birth in term healthy newborn infants. Results Of 127 eligible infants, 59 infants met at least one exclusion criterion and so 68 babies were randomized into two study groups of which 34 received the standard daily dose (400IU) in Group 1 while the other 34 babies in Group 2 were given a single oral bolus dose (50000 IU) of vitamin D soon after birth. Table 1 shows baseline characters of the enrolled groups. In Group 1 the mean vitamin D levels rose from 18.26 ng/ml to 22.9 ng/ml at 1 month of age whereas the change in mean vitamin D levels in Group 2 was from 18.38 ng/ml to 44.25 ng/ml which was statistically significant (p value 150ng/ml) or toxicity (> 250ng/ml). Conclusion A single oral bolus dose of 50,000 IU was found to be convenient, safe and effective in raising vitamin D levels to sufficiency in most babies by 1 month of age but the improvement was not sustained till 4 months of age.