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Comparison of two different vitamin D supplementation regimens with oral calcifediol in kidney transplant patients

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Abstract

Introduction

Vitamin D deficiency is prevalent in kidney transplant recipients (KTR) and recommendations on how to replenish vitamin D deposits are scarce.

Aim

To evaluate, in KTR, the safety and efficacy of calcifediol in two different vitamin D supplementation regimens, in order to assess the most suitable dose.

Patients and methods

Prospective observational study with two calcifediol supplementation regimens randomly prescribed by clinicians in liquid form, at 266 mcg doses, monthly or biweekly. We analyzed 168 KTR with a functioning allograft for more than 6 months. Patients receiving other vitamin D forms, calcimimetics or bisphosphonates were excluded. Before calcifediol initiation (pre-treatment levels) and after at least 3 months of treatment (post-treatment levels), we measured serum levels of 25-OH vitamin D (25(OH)D), parathyroid hormone (PTH), alkaline phosphatase (ALP), calcium (sCa), phosphate (sPO4) and creatinine (sCreat).

Results

In the monthly group (n = 72), 25(OH)D levels increased from 14 ng/ml [interquartile range, IQR 9–22] at baseline to 31 [20–38] (p = 0.000), PTH decreased from 124 pg/ml [87–172] to 114 [78–163] (p = 0.006), while sCa and sPO4 remained stable. In the biweekly group (n = 96), 25(OH)D increased from 14 ng/ml [9–20] at baseline to 39 [28–52] (p = 0), PTH decreased from 141 pg/ml [95–221] to 112 [90–180] (p = 0.000), sCa remained stable and sPO4 increased from 3.3 ± 0.6 mg/dl to 3.5 ± 0.6 (p = 0.003). Renal function remained stable in both groups.

Conclusion

Vitamin D reposition with oral calcifediol, in a biweekly or monthly regimen, is safe and effective in improving 25(OH)D blood levels and in decreasing PTH in kidney transplant recipients.

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Authors and Affiliations

  1. Nephrology and Kidney Transplant Department, Hospital Clinic, Villarroel, 170, 08036, Barcelona, Spain

    Xoana Barros, Nestor Y. Rodríguez, Lida Rodas, Nuria Esforzado & José-Vicente Torregrosa

  2. Nuclear Medicine Department, Hospital Clinic, Barcelona, Spain

    David Fuster, Francisco Campos & Andrés Tapias

  3. Internal Medicine Department, Santa Maria della Misericordia Hospital, Rovigo, Italy

    Alberto Mazza

  4. Nuclear Medicine Department, Santa Maria della Misericordia Hospital, Rovigo, Italy

    Domenico Rubello

Authors
  1. Xoana Barros
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  2. Nestor Y. Rodríguez
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  3. David Fuster
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  4. Lida Rodas
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  5. Nuria Esforzado
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  6. Alberto Mazza
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  7. Domenico Rubello
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  8. Francisco Campos
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  9. Andrés Tapias
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  10. José-Vicente Torregrosa
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Corresponding author

Correspondence to Alberto Mazza.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study protocol was approved by a local ethics committee and institutional review boards, and the study was conducted in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guidelines for Good Clinical Practice. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013.

Informed consent

Informed consent was obtained from all patients for being included in the study.

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Barros, X., Rodríguez, N.Y., Fuster, D. et al. Comparison of two different vitamin D supplementation regimens with oral calcifediol in kidney transplant patients. J Nephrol 29, 703–709 (2016). https://doi.org/10.1007/s40620-015-0237-6

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  • DOI: https://doi.org/10.1007/s40620-015-0237-6

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