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Metabolic Changes Following 500 μg Monthly Administration of Calcidiol: A Study in Normal Females

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Abstract

This study was performed to investigate the effect of monthly oral administration of 500 μg of calcidiol (25-hydroxyvitamin D3) for 4 months on both serum vitamin D levels and sequential changes of parameters of calcium metabolism; 18 normal women aged 24–72 years were investigated. There was a significant increase of serum 25(OH)D after the first administration; thereafter all values persisted significantly higher compared to the basal value (P < 0.001). Mean 1,25(OH)2D serum levels peaked at day 3 and then tended to stabilize following day 30. During the first month, all mean values observed following the initial administration were significantly higher than basal values. The first calcidiol dose produced a significant reduction of serum PTH levels (P < 0.001), which then remained constant over time. Concerning serum calcium and phosphorus, we were not able to demonstrate any significant change during the entire observation period. Considering the single values for both serum ionized and total calcium, the values of Ca2+ exceeded upper limits of normal on only two occasions. Regarding biochemical markers of bone remodeling, mean changes of serum bone isoenzyme of alkaline phosphatase activity showed a significant trend to decrease, starting at day 30. No significant changes of serum CTX values were noted. Overall, 24-h urinary excretion of calcium did not change, seven values exceeding the threshold of 4 mg/kg body weight. Monthly administration of 500 μg of 25-hydroxyvitamin D3 may be considered an alternative for vitamin D repletion, without any detrimental effect.

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Acknowledgement

This study was partly funded by Bruno Farmaceutici, Rome, Italy.

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Authors and Affiliations

  1. Department of Internal Medicine and Medical Disciplines, “Sapienza,” University of Rome, Via del Policlinico 155, 00161, Rome, Italy

    Stefania Russo, Luciano Carlucci, Cristiana Cipriani, Sara Piemonte, Romano Del Fiacco, Jessica Pepe, Valeria Fassino, Elisabetta Romagnoli & Salvatore Minisola

  2. Internal Medicine and Nephrology, “Regina Apostolorum” Hospital, Via san Francesco 50, Albano Laziale, 00041, Rome, Italy

    Alessandro Ragno

  3. Department of Methods and Models for Economy, Territory, and Finance, “Sapienza’’, University of Rome, Via del Castro Laurenziano 9, 00161, Rome, Italy

    Serena Arima

Authors
  1. Stefania Russo
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  2. Luciano Carlucci
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  3. Cristiana Cipriani
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  4. Alessandro Ragno
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  5. Sara Piemonte
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  6. Romano Del Fiacco
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  7. Jessica Pepe
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  8. Valeria Fassino
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  9. Serena Arima
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  10. Elisabetta Romagnoli
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  11. Salvatore Minisola
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Corresponding author

Correspondence to Salvatore Minisola.

Additional information

S. Minisola has served as speaker for Abiogen, Amgen, Bruno Farmaceutici, Eli Lilly, Merck Sharp & Dohme, Nycomed, Neopharmed, Roche, and Warner Chilcott. He also served in advisory boards of Amgen, Eli Lilly, Glaxo SmithKline, Medtronic, Merck Sharp & Dohme, Novartis, and Pfizer. All other authors have stated that they have no conflict of interest.

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Russo, S., Carlucci, L., Cipriani, C. et al. Metabolic Changes Following 500 μg Monthly Administration of Calcidiol: A Study in Normal Females. Calcif Tissue Int 89, 252–257 (2011). https://doi.org/10.1007/s00223-011-9513-1

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  • DOI: https://doi.org/10.1007/s00223-011-9513-1

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