Long-Term Bioavailability After a Single Oral or Intramuscular Administration of 600,000 IU of Ergocalciferol or Cholecalciferol: Implications for Treatment and Prophylaxis

Cipriani, Cristiana; Romagnoli, Elisabetta; Pepe, Jessica; Russo, Stefania; Carlucci, Luciano; Piemonte, Sara; Nieddu, Luciano; McMahon, Donald J.; Singh, Ravinder J.; Minisola, Salvatore

doi:10.1210/jc.2013-1586

Cited by 79 publications

(62 citation statements)

References 39 publications

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“…12,17,31 A similar dose has been found to be sufficient to prevent fractures. 82,83 The American Geriatrics Society recommended a vitamin D dose of 800 IU/day (and calcium) for nursing home patients; however, our observations showed this to be inadequate for maintaining serum concentrations of 25-hydroxyvitamin D let alone correcting low concentrations; thus repeated treatments with high doses are necessary, as illustrated in Figure 2. As mentioned earlier, since the beginning of this study, the American Geriatrics Society has revised the recommendation to increase the intake to 4000 IU/day.…”

Section: Discussionmentioning

confidence: 81%

“…While high doses given at less frequent intervals may be adequate to rectify deficiency and maintain normal concentrations, regular dosing may be better for compliance and is a more physiological approach. 83,84 The lack of response to generally recommended supplementation might be due to poor compliance. We recognize the issue of nonadherence to treatment as having the potential for making the response to treatment seem like an inadequate response.…”

Section: Discussionmentioning

confidence: 99%

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A Predictive Equation to Guide Vitamin D Replacement Dose in Patients

Singh

Bonham

2014

The Journal of the American Board of Family Medicine

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Background: Vitamin D is essential for bone health and probably the health of most nonskeletal tissues. Vitamin D deficiency is widespread, and recommended doses are usually inadequate to maintain healthy levels. We conducted a retrospective observational study to determine whether the recommended doses of vitamin D are adequate to correct deficiency and maintain normal levels in a population seeking health care. We also sought to develop a predictive equation for replacement doses of vitamin D.

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Section: Discussionmentioning

confidence: 81%

Section: Discussionmentioning

confidence: 99%

A Predictive Equation to Guide Vitamin D Replacement Dose in Patients

Singh

Bonham

2014

The Journal of the American Board of Family Medicine

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“…Oral or IM vitamin D was given to 24 normal volunteers (age, 50-78 years) in a dose of 600,000 IU of D 2 or D 3 [70] . Peak levels of 25OHD were seen at 30 and 120 days in those given oral and IM treatment, respectively.…”

Section: Evidencementioning

confidence: 99%

Global Consensus Recommendations on Prevention and Management of Nutritional Rickets

Munns¹,

Shaw²,

Kiely³

et al. 2016

Horm Res Paediatr

359

477

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Background: Vitamin D and calcium deficiencies are common worldwide, causing nutritional rickets and osteomalacia, which have a major impact on health, growth, and development of infants, children, and adolescents; the consequences can be lethal or can last into adulthood. The goals of this evidence-based consensus document are to provide health care professionals with guidance for prevention, diagnosis, and management of nutritional rickets and to provide policy makers with a framework to work toward its eradication. Evidence: A systematic literature search examining the definition, diagnosis, treatment, and prevention of nutritional rickets in children was conducted. Evidence-based recommendations were developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system that describes the strength of the recommendation and the quality of supporting evidence. Process: Thirty-three nominated experts in pediatric endocrinology, pediatrics, nutrition, epidemiology, public health, and health economics evaluated the evidence on specific questions within five working groups. The consensus group, representing 11 international scientific organizations, participated in a multiday conference in May 2014 to reach a global evidence-based consensus. Results: This consensus document defines nutritional rickets and its diagnostic criteria and describes the clinical management of rickets and osteomalacia. Risk factors, particularly in mothers and infants, are ranked, and specific prevention recommendations including food fortification and supplementation are offered for both the clinical and public health contexts. Conclusion: Rickets, osteomalacia, and vitamin D and calcium deficiencies are preventable global public health problems in infants, children, and adolescents. Implementation of international rickets prevention programs, including supplementation and food fortification, is urgently required. nology, pediatrics, nutrition, epidemiology, public health, and health economics evaluated the evidence on specific questions within five working groups. The consensus group, representing 11 international scientific organizations, participated in a multiday conference in May 2014 to reach a global evidence-based consensus. Results: This consensus document defines nutritional rickets and its diagnostic criteria and describes the clinical management of rickets and osteomalacia. Risk factors, particularly in mothers and infants, are ranked, and specific prevention recommendations including food fortification and supplementation are offered for both the clinical and public health contexts. Conclusion: Rickets, osteomalacia, and vitamin D and calcium deficiencies are preventable global public health problems in infants, children, and adolescents. Implementation of international rickets prevention programs, including supplementation and food fortification, is urgently required. Key WordsRickets · Nutrition · Vitamin D · Calcium · Consensus recommendations Abstract Background: Vitamin D and ca...

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“…Therefore, high bolus doses (also referred to as mega doses) of cholecalciferol have been suggested and employed in order to achieve, in a relatively short time, the target levels of serum 25(OH)D necessary to begin osteoporosis treatment in subjects at increased risk of fracture [18]. Although the high doses of cholecalciferol (up to 10,000 IU per day) are safe as far as the classic side effects (hypercalciuria and hypercalcemia) are concerned [19,20], unphysiologically high annual doses of vitamin D (300,000 to 500,000 IU) have been associated with an increased risk in falls and fractures [21,22].…”

Section: Introductionmentioning

confidence: 99%

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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Long-Term Bioavailability After a Single Oral or Intramuscular Administration of 600,000 IU of Ergocalciferol or Cholecalciferol: Implications for Treatment and Prophylaxis

Abstract: A po dose of 600,000 IU of D₂ or D₃ is initially more effective in increasing serum 25(OH)D than the equivalent im dose and is rapidly metabolized. Our RIA assay for 1,25(OH)₂D may not recognize 1,25(OH)₂D₂.

Cited by 79 publications

References 39 publications

A Predictive Equation to Guide Vitamin D Replacement Dose in Patients

A Predictive Equation to Guide Vitamin D Replacement Dose in Patients

Global Consensus Recommendations on Prevention and Management of Nutritional Rickets

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

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