Tóth Béla E, Takács István, Kádár Kristóf, Mirani Sara, Vecsernyés Miklós, Lakatos Péter
Department of Pharmaceutical Surveillance and Economy, Faculty of Pharmacy, University of Debrecen, 4032 Debrecen, Hungary.
Department of Internal Medicine and Oncology, Semmelweis University, 1085 Budapest, Hungary.
Pharmaceuticals (Basel). 2024 Nov 30;17(12):1620. doi: 10.3390/ph17121620.
Epidemiological data on vitamin D status revealed that, despite various dosage and durations of supplementation, the effectiveness often fails to achieve optimal outcomes. The need for higher doses than previously recommended was suggested, but several modifying factors should be considered, including the level of deficiency, and BMI. The objectives of this post hoc evaluation are to characterize treatment effectiveness based on the applied dose, duration and BMI; and to assess the safety aspects associated with rapid repletion of vitamin D. Vitamin D deficient subjects selected in the post-hoc analysis: seventy patients included from a combined loading-maintenance supplementation (300,000 IU followed by 60,000 IU) protocol and 62 deficient subjects who received a low-dose maintenance (1000 IU/day) therapy. The risk of overload and the incidence of hypercalciuria and hypercalcemia resulting from loading or post-loading maintenance were investigated. The moderate-fast-loading schedule of 60,000 IU per week for 5 weeks, effectively achieves the target in 25(OH)D levels over 30 ng/mL for all deficient subjects, regardless of their BMI. Slower loading with lower weekly doses confirms the safety of supplementation, but the effectiveness is dependent on the subjects' BMI; overweight and obese patients require higher doses to reach the same vitamin D levels. No difference in safety parameters observed compared to low-dose therapies. The loading treatment involving a total dose of 300,000 IU administered over 5 or 10 weeks is effective for repletion, does not lead to 25(OH)D overload, and poses no additional risks of hypercalcemia or hypercalciuria. Furthermore, there are no safety concerns regarding changes in bone resorption markers. A combination of the loading treatment with a subsequent maintenance dose of 2000 IU daily is adequate to achieve the target vitamin D levels.
维生素D状态的流行病学数据显示，尽管补充剂量和持续时间各不相同，但效果往往未能达到最佳结果。有人建议需要比先前推荐的剂量更高，但应考虑几个修正因素，包括缺乏程度和体重指数。这项事后评估的目的是根据应用剂量、持续时间和体重指数来描述治疗效果；并评估与维生素D快速补充相关的安全性。事后分析中选择的维生素D缺乏受试者：70名患者来自联合负荷-维持补充方案（300,000国际单位，随后为60,000国际单位），62名缺乏受试者接受低剂量维持（1000国际单位/天）治疗。研究了负荷或负荷后维持导致的过载风险以及高钙尿症和高钙血症的发生率。每周60,000国际单位、持续5周的中度快速负荷方案，对于所有缺乏受试者，无论其体重指数如何，都能有效使25(OH)D水平达到30 ng/mL以上的目标。较低每周剂量的较慢负荷证实了补充的安全性，但效果取决于受试者的体重指数；超重和肥胖患者需要更高剂量才能达到相同的维生素D水平。与低剂量疗法相比，未观察到安全参数有差异。在5周或10周内给予总剂量300,000国际单位的负荷治疗对补充有效，不会导致25(OH)D过载，也不会带来高钙血症或高钙尿症的额外风险。此外，对于骨吸收标志物的变化不存在安全担忧。负荷治疗与随后每天2000国际单位的维持剂量相结合足以达到目标维生素D水平。
