Vitamin D supplementation therapy ? comparison of efficacy of three different protocols

Background: To study the efficacy of vitamin D supplementation therapy with three different protocols. Methods: In protocols 1 (intensive) and 3 (standard) oral cholecalciferol was given 60,000 IU/week/8 weeks followed bimonthly for 12 weeks. In protocol 2 parenteral-bolus cholecalciferol was given as 600,000 IU loading dose, 8 weeks later followed by cholecalciferol 60,000IU bimonthly for 12 weeks. Elemental calcium (1 g/day) was administered for full duration of study in all three protocols. Serum albumin, calcium, phosphorous, alkaline phosphatase, 25-hydroxy vitamin D (25OHD) and parathyroid hormone were tested at baseline, at 2nd, and 5th months. Statistical analysis was performed using random measures analysis of variance. As patients receiving protocol 3 were significantly older compared to the other two groups, age-adjusted analysis was carried out. Results: Intention-to-treat and per-protocol analysis showed that patients receiving protocol 2 had achieved 25OHD sufficiency levels at 8 weeks suggesting that protocol 2 appeared to perform best among the three protocols. However, these differences were not sustained at 5 months suggesting the need for continuing supervision. Conclusions: Despite varied responses of different biochemical markers, all three protocols were effective in bringing up 25OHD levels. However, protocol 2 performed the best among the three protocols. Our observation also highlight the importance of need for ongoing supplementation and continuing supervision of the same.