calciol

ChEBI · EMBL-EBI ↗ · Källdatum saknas · Källans villkor

A hydroxy seco-steroid that is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene in which the pro-S hydrogen at position 3 has been replaced by a hydroxy group. It is the inactive form of vitamin D3, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone.

U.S. Food and Drug Administration (FDA) · Substances Added to Food ↗ · 28 juli 2026 · Källans villkor

Used for*^{†} (Technical Effect): | NUTRIENT SUPPLEMENT

U.S. Food and Drug Administration (FDA) · Substances Added to Food ↗ · 28 juli 2026 · Källans villkor

* Used for^{†} (Technical Effect): The physical or technical effect(s) the substance has in or on food; see 21 CFR 170.3(o) for definitions.

Angelo Fassio; Davide Gatti; Maurizio Rossini; Camilla Benini; Elena Fracassi; Eugenia Bertoldo; Ombretta Viapiana; Stefano Milleri; Matteo Gatti; Giovanni Adami ↗ · 2 juli 2021 · Källans villkor

This was a single-centre, open-label, randomized, parallel group phase I (bioequivalence) study in male and female healthy individuals that was aimed to specifically compare the PK and PD profiles of cholecalciferol (DIBASE®, Abiogen Pharma, Pisa, Italy) administered as repeated once daily (10,000 IU/day for 8 weeks followed by 1000 IU daily for 4 weeks; group A), weekly (50,000 IU/week for 12 weeks; group B), and in alternate week doses (100,000 IU every other week for 12 weeks; group C). The regimens adopted in this trial correspond to the highest dosages allowed for oral cholecalciferol (DIBASE®) in Italy, according to its Summary of Product Characteristics (SmPC), for the correction of vitamin D deficiency in adults [20]. This study was undertaken (first enrollment to end of study) from September 2017 to June 2018.

Angelo Fassio; Davide Gatti; Maurizio Rossini; Camilla Benini; Elena Fracassi; Eugenia Bertoldo; Ombretta Viapiana; Stefano Milleri; Matteo Gatti; Giovanni Adami ↗ · 2 juli 2021 · Källans villkor

Overall levels of 1,25-dihydroxyvitamin D for all individuals showed an increase at Day 28, Day 56, Day 84, and Day 112. This increase was greater (p < 0.05) for Group A vs. B and C at Day 28, and vs. just group B at Day 56. Ionized calcium for all individuals slightly decreased after one month and at Day 56 and 84, with no significant differences among the different groups. Overall, no significant change was found for 24,25-dihydroxyvitamin D over time. PTH significantly decreased after three months. FGF-23 levels for all individuals were observed to increase at all time points, with no significant differences among the different groups. CTX-I levels showed a slight increase in all individuals at the first month at Day 28 only, with no significant differences among the different groups. P1NP levels were observed to significantly increase in all individuals at Day 28 but then significantly decreased at Day 112, with no significant differences among the different groups. BALP levels in all individuals slightly decreased from Day 56 onwards, with no statistically significant differences among the different groups. There was a statistically significant increase (p < 0.05) in the level of Dkk-1 for Groups A, B, and C at Day 56, 84, and 112 compared to baseline levels. Sclerostin remained stable over time, without significant differences seen among the different groups.

Angelo Fassio; Davide Gatti; Maurizio Rossini; Camilla Benini; Elena Fracassi; Eugenia Bertoldo; Ombretta Viapiana; Stefano Milleri; Matteo Gatti; Giovanni Adami ↗ · 2 juli 2021 · Källans villkor

In this study, we described the PD of cholecalciferol supplementation on healthy individuals deficient in vitamin D and compared the effects of three different administration schedules. Differences in PK among the three different groups have already been reported in a previous paper [19], and showed a higher systemic 25OHD exposure in the group treated with the daily dose. Conversely, our present data demonstrate noteworthy effects on PD parameters, but do not show any significant differences in the effect of the administration schedule on vitamin D metabolites (24,25OH2D and 1,25OH2D), endocrine and autocrine/paracrine bone-regulating mediators (PTH, FGF-23 and Dkk-1 and sclerostin, respectively), and bone turnover markers (CTX-I, PINP, and BALP).

Angelo Fassio; Davide Gatti; Maurizio Rossini; Camilla Benini; Elena Fracassi; Eugenia Bertoldo; Ombretta Viapiana; Stefano Milleri; Matteo Gatti; Giovanni Adami ↗ · 2 juli 2021 · Källans villkor

Our study has some limitations worth mentioning. Participants received oral cholecalciferol supplementation for only 12 weeks. A longer treatment period may have revealed additional information on the endpoints examined. As reported previously in detail [19], treatment at the maximum allowed dose of 10,000 IU can result in mild or moderate side effects that are important to monitor. We measured the vitamin D metabolites’ serum level by immunoenzymatic reaction (ELISA), an assay that may be affected by different variables (i.e., pregnancy, severe illnesses) [49,50]. Nevertheless, we studied a healthy (although vitamin D deficient) population, and for this reason we do not expect these issues to undermine our results. For the same reason, caution should be taken before generalizing our results to a diseased population (i.e., the frail elderly, patients affected by chronic illnesses, malabsorption), because, as already discussed, the absorption and/or the destiny of vitamin D metabolites might be different in these settings.

U.S. Food and Drug Administration (FDA) · Substances Added to Food ↗ · 28 juli 2026 · Källans villkor

It is important to note that the inventory is only a partial list of food ingredients.