Effects of Weekly Supplementation of Cholecalciferol and Calcifediol Among the Oldest-Old People: Findings From a Randomized Pragmatic Clinical Trial

Ruggiero, Carmelinda; Baroni, Marta; Bini, Vittorio; Brozzetti, Annalisa; Parretti, Luca; Zengarini, Elisa; Lapenna, Maria; Antinolfi, Pierluigi; Falorni, Alberto; Mecocci, Patrizia; Boccardi, Virginia

doi:10.3390/nu11112778

Cited by 22 publications

(37 citation statements)

References 38 publications

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“…In agreement with previous studies [18,23], 1,25(OH)2D levels similarly increased in the first 30 days of treatment in both group 1 and group 2 (+ 12.7 pg/ml and + 11.2 pg/ ml, respectively); afterwards, the levels of 1,25(OH)2D showed a tendency towards reduction. The observation of the tendency over time of serum levels of 25OHD and of 1,25(OH)2D to stabilize seems to suggest that the two dose regimens of calcifediol do not overwhelm the compensatory mechanisms of calcium homeostasis.…”

Section: Discussionsupporting

confidence: 92%

Pharmacokinetic profile and effect on bone markers and muscle strength of two daily dosage regimens of calcifediol in osteopenic/osteoporotic postmenopausal women

et al. 2021

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Background At present, although cholecalciferol represents the form of vitamin D of choice for the treatment of vitamin D deficiency, there is a growing interest in calcifediol. Aims This study aimed to evaluate the efficacy and the safety of two different daily doses of calcifediol. Methods Fifty osteopenic/osteoporotic women with serum levels of 25-hydroxyvitamin D (25OHD) between 10 and 20 ng/ml were randomized to a 6-month treatment with oral calcifediol 20 µg/day (n = 25) or oral calcifediol 30 µg/day (n = 25). In all, we measured the time course of the levels of 25OHD and other biochemical parameters. Moreover, we evaluated handgrip strength and serum levels of myostatin. Results The peak increase in 25OHD levels was reached after 90 days of treatment in group 1 (59.3 ng/ml) and after only 60 days in group 2 (72.3 ng/ml); thereafter in both groups, the levels of 25OHD showed a tendency towards stabilization. After 30 days, all the patients treated with 30 µg/day had values of 25OHD > 30 ng/ml. Handgrip strength showed a modest but progressive increase which reached the statistical significance in the 30 µg/day group. This latter group also presented a modest and non-significant decrease in serum levels of myostatin. Conclusions Calcifediol is able to rapidly normalize the vitamin D deficiency, and the 30 µg daily dosage could be suggested in those patients who need to rapidly reach optimal 25OHD levels. Moreover, the 6-month treatment with calcifediol at a dose of 30 µg results in a modest but significant increase in upper limb strength.

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Section: Discussionsupporting

confidence: 92%

Pharmacokinetic profile and effect on bone markers and muscle strength of two daily dosage regimens of calcifediol in osteopenic/osteoporotic postmenopausal women

et al. 2021

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“…Remarkably, iPTH levels decreased significantly after 12 months. In a study performed in an elderly population (≥75 years of age) by Ruggiero et al, ( 32 ) calcifediol rapidly increased serum 25 (OH)D levels and reached the optimal target threshold (defined as 22–30 ng/ml). This was particularly marked among those with comorbidity, taking multiple drugs and showing low muscle strength.…”

Section: Discussionmentioning

confidence: 99%

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial

Pérez‐Castrillón

Dueñas‐Laita

Brandi

et al. 2020

Journal of Bone and Mineral Research

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Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean AE standard deviation change = 9.7 AE 6.7 and 5.1 AE 3.5 ng/ml in patients treated withThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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“…Supplementation with calcifediol has been reported in an efficient manner to correct poor vitamin D status in several studies [ 165 , 166 , 167 , 168 , 169 , 170 , 171 , 172 , 173 , 174 , 175 , 176 , 177 , 178 ] ( Table 7 ). Even if the most common form of vitamin D supplementation used today is cholecalciferol, the usual recommended doses are frequently not able to rapidly correct vitamin D insufficiency, especially in severe cases.…”

Section: Vitamin D Deficiencymentioning

confidence: 99%

Vitamin D Sources, Metabolism, and Deficiency: Available Compounds and Guidelines for Its Treatment

et al. 2021

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Studies on vitamin/hormone D deficiency have received a vast amount of attention in recent years, particularly concerning recommendations, guidelines, and treatments. Moreover, vitamin D’s role as a hormone has been confirmed in various enzymatic, metabolic, physiological, and pathophysiological processes related to many organs and systems in the human body. This growing interest is mostly due to the evidence that modest-to-severe vitamin D deficiency is widely prevalent around the world. There is broad agreement that optimal vitamin D status is necessary for bones, muscles, and one’s general health, as well as for the efficacy of antiresorptive and anabolic bone-forming treatments. Food supplementation with vitamin D, or the use of vitamin D supplements, are current strategies to improve vitamin D levels and treat deficiency. This article reviews consolidated and emerging concepts about vitamin D/hormone D metabolism, food sources, deficiency, as well as the different vitamin D supplements available, and current recommendations on the proper use of these compounds.

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Effects of Weekly Supplementation of Cholecalciferol and Calcifediol Among the Oldest-Old People: Findings From a Randomized Pragmatic Clinical Trial

Cited by 22 publications

References 38 publications

Pharmacokinetic profile and effect on bone markers and muscle strength of two daily dosage regimens of calcifediol in osteopenic/osteoporotic postmenopausal women

Pharmacokinetic profile and effect on bone markers and muscle strength of two daily dosage regimens of calcifediol in osteopenic/osteoporotic postmenopausal women

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial

Vitamin D Sources, Metabolism, and Deficiency: Available Compounds and Guidelines for Its Treatment

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