Abstract
Objectives
To compare the change in serum vitamin D levels and to compare the changes in serum levels of calcium, phosphate, alkaline phosphatase and parathyroid hormone in vitamin D supplemented and unsupplemented groups after 3 mo.
Methods
In this randomized, parallel group, nonblinded, controlled trial, 40 children, 2–12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy, were randomized into the intervention group (n = 20), which was given daily oral 600 IU vitamin D supplementation, and the control group (n = 20), which was not given any supplementation. Changes in the biochemical parameters was measured in the two groups after 3 mo.
Results
There was a significant reduction in the median (IQR) vitamin D levels in the control group as compared to an increase seen in the intervention group [−6.64 (−8.4, −2.65) vs. 5.66 (1.81, 7.12); p < 0.001]. In the control group, 37.5% children developed vitamin D insufficiency and 12.5% developed deficiency whereas only 5% of the intervention group developed vitamin D insufficiency (p = 0.005). There was a significant decrease in ionized calcium (p = 0.02), increase in serum phosphate (p = 0.02), and alkaline phosphatase level (p = 0.003) in the unsupplemented group as compared to the supplemented group.
Conclusion
Vitamin D supplementation can reduce the valproate-associated decline in vitamin D levels and the negative impact on other markers of bone mineral metabolism.
Trial Registration
TCTR20200621002, 19.06.2020, retrospectively registered.
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DM conceptualized and planned the study, supervised the conduct of the study, and assisted in the statistical analysis and finalization of the manuscript; SM assisted in planning the study and statistical analysis, evaluated and enrolled the patients and carried out sample collection, carried out follow-up and assessed the outcomes, and prepared the initial draft of the manuscript; MM provided important intellectual inputs in planning and conduct of the study, and assisted in manuscript preparation; BM provided important intellectual inputs in planning and conduct of the study, and supervised the sample storage and analysis; AMK provided important intellectual inputs in planning and conduct of the study, and the data analysis. All authors approved the final manuscript. DM will act as the guarantor for this paper.
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This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Maulana Azad Medical College, University of Delhi (F.No./17/IEC/MAMC/2018/09).
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Informed consent was taken from parents and assent was taken from all participants 7 to 12 y of age.
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Mishra, S., Mishra, D., Mahajan, B. et al. Effect of Daily Vitamin D Supplementation on Serum Vitamin D Levels in Children with Epilepsy Receiving Sodium Valproate Monotherapy: A Randomized, Controlled Trial. Indian J Pediatr 90, 450–456 (2023). https://doi.org/10.1007/s12098-022-04225-w
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DOI: https://doi.org/10.1007/s12098-022-04225-w