Effectiveness and Safety of Vitamin D3 Supplementation in Children Across India: A Retrospective Real-World Evidence Study
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Abstract
Objective: To assess the real-world effectiveness and safety of vitamin D3 supplementation in children. Design: A retrospective, multicentre, observational real-world evidence study. Subjects/Patients: Children aged 0–12 years with documented vitamin D deficiency who received vitamin D3 supplementation for at least two months were included. Methods: Data from electronic health records (2014–2024) were analyzed. Outcomes assessed included changes in serum vitamin D levels, clinical improvements, and adverse effects. Results: A total of 1,942 children were evaluated. Mean serum vitamin D levels significantly increased from 18.01 ng/mL (±8.73) to 35.29 ng/mL (±13.53) following supplementation (p < 0.001). Greater improvement was observed in children with poorer baseline health. Adverse events were reported in only 0.21% of participants, and were mild, primarily involving transient gastrointestinal symptoms. Conclusion: Vitamin D3 supplementation is effective in correcting vitamin D deficiency and improving health outcomes in children, with minimal side effects. These findings offer valuable real-world evidence supporting its clinical use in Indian pediatric populations. Further randomized controlled trials are recommended to confirm these results and guide optimal dosing strategies.
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Copyright (c) 2025 Chaudhari V.L., DM, Madkholkar N., MD, Pawar R.R., MD, Sharma A.D., MD
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons License All articles published in Annals of Medicine and Medical Sciences are licensed under a Creative Commons Attribution 4.0 International License.
Chaudhari V.L., DM, Senior Medical Advisor, Alkem Laboratories, Mumbai-400013, Maharashtra, India.
MBBS, MD Pharmacology, DM Clinical Pharmacology
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