A Randomized Controlled Trial on Safety and Efficacy of Single Intramuscular versus Staggered Oral Dose of 600 000IU Vitamin D in Treatment of Nutritional Rickets by Krishanu Mondal, 1 Anju Seth, 1 Raman K. Marwaha, 2 Dinesh Dhanwal, 3 Satinder Aneja, 1 Ritu Singh, 4 and Pitambar Sonkar 5 1 Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children’s Hospital, New Delhi, DL 110001, India 2 Department of Endocrinology, Institute of Nuclear Medicine and Allied Sciences, New Delhi, DL 110001, India 3 Department of Medicine, Maulana Azad Medical College, New Delhi, DL 110001, India 4 Department of Biochemistry, Lady Hardinge Medical College, New Delhi, DL 110001, India 5 Department of Radiology, Lady Hardinge Medical College, Kalawati Saran Children’s Hospital, New Delhi, DL 110001, India Correspondence: Anju Seth, Department of Paediatrics, Kalawati Saran Children’s Hospital, Bangla Sahib Marg, New Delhi-100001, India. Tel/Fax no. 911123365792; E-mail<anjuseth.peds@gmail.com>. Summary Objective: Comparison of efficacy and safety of two different regimens of vitamin D—600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks—in treatment of nutritional rickets. Methods: Children with nutritional rickets (age: 0.5–5 years, n ¼ 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up. Results: No difference was found in efficacy of the two regimens on comparing biochemical and radio- logical parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment. Conclusion: Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets. Key words: Vitamin D, 25(OH)D, radiological score, nutritional rickets. Introduction Role of vitamin D and calcium in treatment of nu- tritional rickets is well established. Most authorities recommend daily or weekly administration of vita- min D orally or parenterally in treatment of rickets [1–3]. A common practice is to administer vitamin D 600 000IU intramuscularly as a bolus dose. Although convenient, administration of a large single dose of vitamin D is reported to cause hypercalcemia and hypercalciuria, thereby raising a concern about its safety [4–6]. Asymptomatic hypercalcemia has been implicated in development of nephrocalcinosis and coronary artery disease [7]. There is no consensus on optimal route of vitamin D administration in treatment of rickets. While effi- cacy of oral administration has been demonstrated, it may not be an optimal therapy when compliance cannot be ensured [8–11]. Lubani et al found a daily oral vitamin D dose to be less effective as compared with a single bolus intramuscular dose [11]. Stogman et al reported equal efficacy of bolus versus staggered oral regimens in treatment of rickets [12]. The present study was planned to compare efficacy and safety of two different regimens of vitamin D— 600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks—in treat- ment of nutritional rickets during a 12-week follow-up. Methods Study design This randomized controlled trial was carried out in the Department of Pediatrics, Lady Hardinge JOURNAL OF TROPICAL PEDIATRICS, VOL. 60, NO. 3, 2014 ß The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com 203 doi:10.1093/tropej/fmt105 Advance Access published on 8 January 2014 Downloaded from https://academic.oup.com/tropej/article/60/3/203/1621752 by guest on 05 December 2023