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 < 0.0001). When followed at four months of age, this improvement was not sustained as 25% infants had vitamin D levels in deficient range, 40% in insufficient range and sufficiency was achieved only in 36%. At 4 months, the mean vitamin D value of Group 1 was 29.96 ng/ml and in Group 2 was 28.9 ng/ml which were comparable (p value = 0.705). No significant difference in serum calcium and phosphate levels was found at 4 months of age, but alkaline phosphatase levels were still significantly lower in group 2 with mean value of 168.5 + 50.9 U/L (p value < 0.0001). Figure 1 shows the trend of vitamin D in both study groups. Hypercalcemia was not seen in any infant. None of the babies from the study population developed vitamin D excess (> 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.