Ergocalciferol 1.25 mg
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Ergocalciferol 1.25 mg: Applications and Efficacy
Determination of Ergocalciferol in Human Plasma
LC-MS/MS Method for Ergocalciferol Quantification
A highly sensitive and selective method has been developed for the determination of ergocalciferol (vitamin D2) in human plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS). This method involves a liquid-liquid extraction process followed by derivatization using 4-phenyl-1,2,4-triazoline-3,5-dione (PTAD), which enhances the detection sensitivity through a Diels-Alder reaction. The analysis is performed on an X Select CSH C18 column with a gradient elution mode, achieving a detection sensitivity of 0.10 ng/mL and an extraction efficiency of over 83%. This method is particularly advantageous due to its high throughput, data integrity, and operational efficiency, making it suitable for bioequivalence studies of ergocalciferol capsules.
Bioequivalence Study of Ergocalciferol Capsules
The developed LC-MS/MS method was successfully applied in a bioequivalence study involving 1.25 mg ergocalciferol capsules administered to 12 healthy subjects. The study demonstrated that the method is linear within the concentration range of 0.10-100 ng/mL for ergocalciferol, with intra-batch and inter-batch accuracy and precision values ranging from 97.3% to 109.0% and 1.01% to 5.16%, respectively. This indicates that the method is reliable and robust for clinical pharmacokinetic studies.
Ergocalciferol Supplementation in Hemodialysis Patients
Effects on Vitamin D Levels and Epoetin Utilization
A randomized clinical trial investigated the effects of ergocalciferol supplementation in hemodialysis patients with vitamin D deficiency. The study included 276 patients who were randomized to receive either ergocalciferol or a placebo for six months. Results showed that ergocalciferol supplementation significantly increased serum 25-hydroxyvitamin D (25(OH)D) levels from 16.0±5.9 ng/mL to 39.2±14.9 ng/mL, while no significant change was observed in the placebo group. However, there was no significant impact on epoetin utilization, with both the ergocalciferol and placebo groups showing similar geometric mean rates over the study period.
Secondary Biochemical and Clinical Outcomes
The study also assessed various secondary biochemical and clinical outcomes, including serum calcium, phosphorus, intact parathyroid hormone, and C-reactive protein levels. No significant changes were observed in these parameters in either the ergocalciferol or placebo groups. Additionally, there were no differences in the rates of all-cause, cardiovascular, and infection-related hospitalizations between the two groups, although the study was not sufficiently powered to detect differences in these outcomes.
Conclusion
Ergocalciferol 1.25 mg has been effectively quantified in human plasma using a novel LC-MS/MS method, which has proven useful in bioequivalence studies. While ergocalciferol supplementation significantly increases serum 25(OH)D levels in hemodialysis patients with vitamin D deficiency, it does not appear to affect epoetin utilization or other secondary biochemical and clinical outcomes. These findings highlight the importance of further research to fully understand the clinical implications of ergocalciferol supplementation in different patient populations.
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