Relation of Vitamin D Supplementation, upto six months of age with Total and Bone Specifc Alkaline Phosphatase: A Randomised Control Trial

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.