Journal of Clinical and Diagnostic Research, 2018, Oct, Vol-12(10): SC01-SC05 1 1 DOI: 10.7860/JCDR/2018/34751.12095 Original Article Neonatology Section Relation of Vitamin D Supplementation, upto six months of age with Total and Bone Specifc Alkaline Phosphatase: A Randomised Control Trial INTRODUCTION Vitamin D is pivotal for healthy bone mineralisation. The foundation of peak bone mass; an important determinant of osteoporotic fracture risk, is laid down in early infancy [1]. Vitamin D deficiency (<20 ng/mL), leads to defective bone mineralisation and decreased bone mineral content [2]. Its prevalence in term healthy breastfed infants has been reported variably as 20-82% in various studies [3,4]. The deficiency is rising in correspondence with increasing exclusive breastfeeding rates, breast milk being a poor source of vitamin D and inadequate vitamin D supply would imply defective bone mineralisation [5,6]. Vitamin D levels inversely correlate with TALP and BSALP [7]. Osteoblasts, which exhibit receptors for Parathormone (PTH) and vitamin D, secrete TALP and BSALP during bone formation which provide an indirect estimation of dynamics of the bone mineralisation process and have been shown to be a significant marker of Whole Body Bone Mineral Content (WBBMC) in the newborn [7]. Breast milk contains 15-50 IU/L vitamin D, which is insufficient to meet the needs of neonates [5,6]. There exist international recommendations to supplement exclusively breast fed babies with oral vitamin D, however the same has not been substantiated by evidence based studies in India [8]. It was felt that there is a requirement of Indian studies in the matter given that the handling of vitamin D in the body differs in the people of different races, colour and ethnicity. The presence of dark skin, decreased activity of 25(OH) hydroxylase (an enzyme involved in the synthesis of an active form of vitamin D) in Asian population lack of fortification policies in India predispose mothers and their infants to vitamin D deficiency [9]. Another fact is that there is a paucity of data from India regarding the impact of vitamin D supplementation on bone mineralisation in a neonate. Present study was conceptualised to study the impact of vitamin D supplementation on biochemical markers for bone mineralisation, vitamin D status in the body and growth (first six months), in term healthy exclusively breastfed neonates. MATERIALS AND METHODS Subjects and setting: It was an open-label (unblinded), parallel, superiority randomised controlled trial with 1:1 allocation ratio, conducted in post-natal ward setting of Postgraduate Institute of Medical Education and Research and Dr Ram Manohar Lohia Hospital Hospital, New Delhi, India from January 2013 to February 2014 Consecutively born full term healthy neonates born to mothers who were residents of Delhi and chose to exclusively breastfeed their infant and consent for participation in this follow-up study were eligible. Babies with life threatening congenital malformations or born to HIV positive mothers were excluded. Hundred babies HEMLATA SINGH 1 , ARTI MARIA 2 , AMLIN SHUKLA 3 , NEERA SHARMA 4 , KALAIVANI MANI 5 , MANOJ K DAS 6 Keywords: Anthropometry, Control Groups, Peak bone mass ABSTRACT Introduction: Vitamin D deficiency is an issue of concern in the Asian population. In the light of the fact that breast milk is an inadequate source of vitamin D, supplementation becomes essential for all term healthy babies for healthy peak bone mass. However, there is a lack of guidelines and research on this issue in India. Aim: To document change in Total Alkaline Phosphatase (TALP) and Bone Specific Alkaline Phosphatase (BSALP) levels in babies receiving 400 IU/day vitamin D from zero to six months (primary objective) and change in vitamin D, PTH, calcium, phosphorus levels and anthropometry (head circumference, length, weight and mid-arm circumference) (secondary objectives). Materials and Methods: Hundred eligible babies were randomised into two groups by block randomisation using alternate sizes of block four and six and allocation concealment was done through serially numbered opaque sealed envelopes. Both groups were followed over six months at intervals of 2, 6, 10 and 14 weeks to compare the change in levels of BSALP and TALP and also vitamin D, PTH, calcium, phosphorus and anthropometry. Results: There was a statistically significant difference in levels of TALP (p<0.001) however, not in BSALP between two groups at six months (p=0.62). There was a significant rise in vitamin D levels in the supplemented group at the end of six months as compared to control group. 60% babies were vitamin D deficient (<20 ng/mL) at birth in the vitamin D group and 34% in the control group while at six months 40% babies were vitamin D deficient in the supplemented group while 76% in controls (p<0.05). No significant difference in anthropometric indices was seen between the two groups. None had vitamin D toxicity. Conclusion: Vitamin D supplementation in newborns for the initial six months led to a significant change in TALP compared to the control group. However, it did not cause a statistically significant change in BSALP. Prevalence of vitamin D deficiency was almost universal in all the mothers. More than half of the newborns delivered to these mothers were also deficient in vitamin D. Vitamin D supplementation significantly reduced the percentage of vitamin D deficient babies in the supplemented group compared to the control group at the end of six months. Vitamin D supplementation in a dose of 400 IU/day was safe and did not lead to any toxicity.