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

Russo, Stefania; Carlucci, Luciano; Cipriani, Cristiana; Ragno, Alessandro; Piemonte, Sara; Fiacco, R. Del; Pepe, Jessica; Fassino, Valeria; Arima, Susumu; Romagnoli, Elisabetta; Minisola, Salvatore

doi:10.1007/s00223-011-9513-1

Cited by 23 publications

(15 citation statements)

References 25 publications

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“…The similarity of efficacy of the daily and weekly dose regimens (i.e., 20 μg/day and 125 μg/week, respectively) in terms of attaining sufficient levels of 25(OH)D shown in this study confirm previous findings [15], indicating that administering calcidiol every day or administering an equal (140 μg) [15] or similar (125 μg) amount once a week or monthly [27] results in equal effectiveness with respect to attaining desired 25(OH)D levels. The efficacy of the lower dose regimens also demonstrates that there is no need to further increase the dosage in non-obese subjects to correct vitamin D status for optimizing mineral homeostasis.…”

Section: Discussionsupporting

confidence: 88%

“…In this study, no increase of markers of bone turnover (such as serum BALP, CTX, and urinary DPD) was observed for any of the treatments with calcidiol within the whole interval of administration. Furthermore, in a previous study utilizing a monthly dose of 500 μg calcidiol, a decrease of bone alkaline phosphatase was even observed [27].…”

Section: Discussionmentioning

confidence: 89%

“…Calcidiol has proven to be safe when administered at daily, weekly, monthly, or every other week [27] dose regimens. It is commonly used in clinical practice, without risk of vitamin D intoxication (i.e., hypercalciuria and hypercalcemia).…”

Section: Discussionmentioning

confidence: 99%

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Correction of vitamin D status by calcidiol: pharmacokinetic profile, safety, and biochemical effects on bone and mineral metabolism of daily and weekly dosage regimens

et al. 2017

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Summary Rationale: Calcidiol can be employed to correct vitamin D deficiency. Main results: Calcidiol administered at daily and weekly regimens over a period of 3 months was able to successfully raise 25-hydroxyvitamin D levels without altering other markers related to bone and mineral metabolism. Significance: Calcidiol supplementation is effective and safe. Introduction The correction of vitamin D status is necessary to maintain an optimal mineral and skeletal homeostasis. Despite cholecalciferol (vitamin D 3 ) is the most commonly used drug for vitamin D supplementation, the more hydrophilic compound calcidiol (25-hydroxyvitamin D 3 ) can be employed at daily, weekly, and monthly regimens to reach in the short term the target levels of serum 25-hydroxyvitamin D [25(OH)D]. In the administration of different doses of calcidiol pharmacokinetic study (ADDI-D study), the efficacy and safety of daily and weekly dosages of calcidiol were tested. Methods A total of 87 Caucasian, community-dwelling, postmenopausal women, aged 55 years or older, with vitamin D inadequacy (serum 25(OH)D levels <30 ng/ml, with mean 25(OH)D below 20 ng/ml, namely 16.5 ± 7.5 ng/ml) were randomized to receive three different dosages of calcidiol: 20 μg/day, 40 μg/day, and 125 μg/week for 3 months. The attained level of serum 25(OH)D was selected as primary endpoint to assess efficacy, while other parameters of mineral metabolism, (serum calcium, parathyroid hormone, phosphate, FGF23, urinary calcium, and markers of bone turnover) were assessed as secondary endpoints to establish safety. Results In all the three groups, serum 25(OH)D values significantly and promptly rose and plateaued above the 30 ng/ml threshold remaining within safety interval after 14 days of treatment, with similar efficacy for the similar daily and weekly dose regimens. The different dosages were also equally effective in controlling secondary hyperparathyroidism. No significant changes in calcium and phosphate metabolism and in bone turnover markers were observed for any of the treatments, confirming the safety of this compound. Conclusions The results of this study demonstrate the shortand mid-term efficacy and safety on core parameters of mineral metabolism of different daily or weekly dosages of calcidiol when used to treat vitamin D inadequacy or deficiency in postmenopausal women. Further studies are needed to assess falls as primary outcome of calcidiol supplementation.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 89%

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Correction of vitamin D status by calcidiol: pharmacokinetic profile, safety, and biochemical effects on bone and mineral metabolism of daily and weekly dosage regimens

et al. 2017

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“…Available data also document the higher efficacy of cholecalciferol, regardless of the frequency of administration (small daily doses or in larger and more infrequent bolus) (27,88,89,90,91). The monthly administration of 500 mg oral 25(OH)D 3 has been proposed as an alternative for vitamin D repletion, without any detrimental effect (92). In many countries around the world, both cholecalciferol and ergocalciferol are available as oral or i.m.…”

Section: Vitamin D Supplementation: Which Type?mentioning

confidence: 99%

MANAGEMENT OF ENDOCRINE DISEASE: Value and limitations of assessing vitamin D nutritional status and advised levels of vitamin D supplementation

Romagnoli

Pepe

Piemonte

et al. 2013

European Journal of Endocrinology

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The growing attention to the role of vitamin D in skeletal and extra-skeletal diseases over the last decade induced an increased demand for vitamin D determination as well as a dramatic rise of sales of vitamin D supplement. However, several critical points in this field remain to be clarified. We lack a clear consensus about the definition of vitamin D deficiency, insufficiency, and sufficiency. The identification of different thresholds defining vitamin D status has relevant implications in clinical practice. In fact, the worldwide prevalence of low vitamin D status is highly varying according to the level of 25(OH)D utilized to define sufficiency. Therefore, the assessment of 25-hydroxyvitamin D levels may have a critical role, but a number of different technical problems associated with its determination may interfere in interpreting the results. The hydrophobic nature of vitamin D and the tight binding to its carrier (vitamin D binding protein), the different forms circulating in blood, and the issue of standardization are among the most important factors influencing the measurement of this metabolite. Another controversial point relies on the conflicting guidance on prevention and treatment of vitamin D deficiency endorsed by different medical and scientific communities. In particular, uncertainty exists about how to replete vitamin D stores, how to maintain normal 25(OH)D levels after repletion, which form of vitamin D is preferable for supplementation, and which route of administration and dosing regimens are advisable. Finally, concerns have been raised regarding vitamin D toxicity and its adverse effects.

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“…Also, the use of loading doses, followed by a daily or monthly regimen after the threshold for sufficiency is reached, is recommended for severely deficient patients (4,7). Among other precursors of vitamin D employed in clinical practice, calcidiol is the most recently introduced for treatment of hypovitaminosis D (8). Pharmacokinetic studies demonstrated the hydrophilic properties of calcidiol, as well as a shorter half-life (10-13 days) in comparison with cholecalciferol (9).…”

mentioning

confidence: 99%

Oral calcidiol is a good form of vitamin D supplementation

Biondi

Pepe

Biamonte

et al. 2017

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

Cited by 23 publications

References 25 publications

Correction of vitamin D status by calcidiol: pharmacokinetic profile, safety, and biochemical effects on bone and mineral metabolism of daily and weekly dosage regimens

Correction of vitamin D status by calcidiol: pharmacokinetic profile, safety, and biochemical effects on bone and mineral metabolism of daily and weekly dosage regimens

MANAGEMENT OF ENDOCRINE DISEASE: Value and limitations of assessing vitamin D nutritional status and advised levels of vitamin D supplementation

Oral calcidiol is a good form of vitamin D supplementation

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