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300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: A randomized controlled trial

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Abstract

Objective

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.

Design

Randomized, open-labeled, controlled trial.

Setting

Tertiary care hospital.

Participants

76 children (median age 12 mo) with clinical and radiologically confirmed rickets.

Intervention

Oral vitamin D3 as 300,000 IU (Group 1; n=38) or 600,000 IU (Group 2; n=38) in a single day.

Outcome variables

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.

Results

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.

Conclusion

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.

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Authors and Affiliations

  1. Department of Pediatrics, University College of Medical Sciences, Dilshad Garden, New Delhi, 110 095, India

    Hema Mittal, Sunita Rai, Dheeraj Shah & Piyush Gupta

  2. Department of Endocrinology, University College of Medical Sciences, Dilshad Garden, New Delhi, 110 095, India

    S. V. Madhu

  3. Department of Radiology, University College of Medical Sciences, Dilshad Garden, New Delhi, 110 095, India

    Gopesh Mehrotra

  4. Department of Biostatistics, University College of Medical Sciences, Dilshad Garden, New Delhi, 110 095, India

    Rajeev Kumar Malhotra

  5. Block R6A, Dilshad Garden, New Delhi, 110 095, India

    Piyush Gupta

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  1. Hema Mittal
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  2. Sunita Rai
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  7. Piyush Gupta
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Correspondence to Piyush Gupta.

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Mittal, H., Rai, S., Shah, D. et al. 300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: A randomized controlled trial . Indian Pediatr 51, 265–272 (2014). https://doi.org/10.1007/s13312-014-0399-7

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  • DOI: https://doi.org/10.1007/s13312-014-0399-7

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