300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: A randomized controlled trial
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To evaluate the non-inferiority of a lower therapeutic dose (300,000 IU) in comparison to standard dose (600,000) IU of Vitamin D for increasing serum 25(OH) D levels and achieving radiological recovery in nutritional rickets.
Randomized, open-labeled, controlled trial.
Tertiary care hospital.
76 children (median age 12 mo) with clinical and radiologically confirmed rickets.
Oral vitamin D3 as 300,000 IU (Group 1; n=38) or 600,000 IU (Group 2; n=38) in a single day.
Primary: Serum 25(OH)D, 12 weeks after administration of vitamin D3; Secondary: Radiological healing and serum parathormone at 12 weeks; and clinical and biochemical adverse effects.
Serum 25(OH)D levels [geometric mean (95% CI)] increased significantly from baseline to 12 weeks after therapy in both the groups [Group 1: 7.58 (5.50–10.44) to 16.06 (12.71–20.29) ng/mL, P<0.001]; Group 2: 6.57 (4.66–9.25) to 17.60 (13.71–22.60, P<0.001]. The adjusted ratio of geometric mean serum 25(OH)D levels at 12 weeks between the groups (taking baseline value as co-variate) was 0.91 (95% CI: 0.65–1.29). Radiological healing occurred in all children by 12 weeks. Both groups demonstrated significant (P<0.05) and comparable fall in the serum parathormone and alkaline phosphatase levels at 12 weeks. Relative change [ratio of geometric mean (95% CI)] in serum PTH and alkaline phosphatase, 12 weeks after therapy, were 0.98 (0.7–1.47) and 0.92 (0.72–1.19), respectively. The serum 25(OH)D levels were deficient (<20 ng/mL) in 63% (38/60) children after 12 weeks of intervention [Group 1: 20/32 (62.5%); Group 2: 18/28 (64.3%)]. No major clinical adverse effects were noticed in any of the children. Hypercalcemia was documented in 2 children at 4 weeks (1 in each Group) and 3 children at 12 weeks (1 in Group 1 and 2 in Group 2). None of the participants had hypercalciuria or hypervitaminosis D.
A dose of 300,000 IU of vitamin D3 is comparable to 600,000 IU, administered orally, over a single day, for treating rickets in under-five children although there is an unacceptably high risk of hypercalcemia in both groups. None of the regime is effective in normalization of vitamin D status in majority of patients, 3 months after administering the therapeutic dose.
Key WordsChildren Rickets Treatment Serum 25(OH)D Stoss Therapy Vitamin D3
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- 5.Muuns C, Zacharin MR, Rodda CP, Batch JA, Morley R, Cranswick NE, et al. Prevention and treatment of infant and childhood vitamin D in Australia and New Zealand: A consensus statement. Med J Aust. 2006;185:268–272.Google Scholar
- 8.Gupta P, Shah D, Ghai OP. Micronutrients in health and disease. In: Ghai OP, Gupta P, Paul VK (editors). Essential Pediatrics, 6th ed. New Delhi: CBS; 2004. P. 129.Google Scholar
- 9.Ozkan B, Buyukavcï M, Energin M. Nutritional rickets: comparison of three different therapeutic approach 300,000 U p.o., 300,000 IU i.m. and 600,000 IU p.o. Cocuk Sagöligöive Hastaliklari Dergisi. 2000;43:30–35.Google Scholar
- 14.Shah D, Gupta P. Nutrition and health. In: Gupta P, editor. Textbook of Pediatrics. New Delhi: CBS Publishers and Distributors; 2013.p. 51–82.Google Scholar
- 15.WHO. Physical status: The Use and Interpretation of Anthropometry. Report of WHO Expert Committee. Geneva: WHO; 1987.Google Scholar
- 16.World Health Organization. The WHO Child Growth Standards. Available from: http://www.who.int/childgrowth/en/. Accessed on September 11, 2012.
- 18.Merill V. Atlas of Roentgenographic Positions and Standard Radiologic Procedures. Fourth Edition. USA: Mosby; 1975. p. 38 and 92.Google Scholar
- 19.Nicholson JF, Pesce MA. Reference ranges for laboratory tests and procedures. In: Behrman RE, Kliegman RM, editors. Nelson Textbook of Pediatrics. 17th edition. Philadelphia: Saunders; 2003. p. 2396–2427.Google Scholar