Background/Objectives: Given the crucial health benefits of vitamin D, addressing severe deficiencies is a pressing medical concern. This study aimed to evaluate the effectiveness and safety of two new weekly doses of calcifediol (100 µg and 125 µg) for long-term management in patients with severe vitamin D deficiency, defined as plasma 25(OH)D levels ≤10 ng/mL. Methods: This study was a randomized, two-cohort, controlled, double-blind, multicentre phase II-III trial. Subjects were randomized 2:2:1 to weekly calcifediol 100 µg, 125 µg or a placebo. The primary endpoint was the proportion of patients achieving plasma 25(OH)D levels of ≥20 ng/mL and/or ≥30 ng/mL by week 16. Results: A total of 276 patients (mean age: 55.2 years, SD 15.42) were randomized. By week 16, 92.3% and 91.8% of patients in the calcifediol 100 µg and 125 µg groups, respectively, reached ≥20 ng/mL, compared to 7.3% in the placebo group. Levels of ≥30 ng/mL were achieved by 49% (100 µg) and 76.4% (125 µg) of participants, with none in the placebo group. Calcifediol demonstrated superior efficacy at all response levels and time points (p < 0.0001). Plasma 25(OH)D concentrations increased by week 24 and remained stable. The incidence of adverse events was comparable across groups. Conclusions: A weekly calcifediol dose of 100 µg demonstrates the best profile of efficacy and tolerability, providing a reliable solution for achieving and maintaining adequate vitamin D levels in patients with severe deficiency.

• Klíčová slova
• calcifediol, efficacy, safety, vitamin D deficiency, weekly treatment,
• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• kalcifediol * krev   aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nedostatek vitaminu D * farmakoterapie   krev   MeSH
• potravní doplňky MeSH
• rozvrh dávkování léků MeSH
• senioři MeSH
• vitamin D krev   analogy a deriváty   aplikace a dávkování   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• 25-hydroxyvitamin D MeSH Prohlížeč
• kalcifediol * MeSH
• vitamin D MeSH

BACKGROUND/AIM: Low levels of vitamin D are a widespread global issue. This study aimed to determine the optimal vitamin D3 supplementation dose for healthy young adults by comparing the effectiveness of gradually increasing cholecalciferol doses over two years. PATIENTS AND METHODS: Thirty-five volunteers participated in a two-season pilot study conducted from October to April to avoid sunlight-induced vitamin D3 synthesis. The participants used oil-based drops of cholecalciferol, increasing their dose from 1,000 to 2,000, 4,000, and then 8,000 IU daily for 60 days with a 30-day break. RESULTS: Supplementing with 1,000 IU/day raised vitamin D levels to the recommended range (above 75 nmol/l), but levels dropped below this range after a 30-day break. A dose of 2,000 IU/day maintained vitamin D levels within the recommended range, even after the break. Increasing the dose to 4,000 IU/day produced a rapid rise, though levels dropped more significantly after stopping supplementation. With 8,000 IU/day, both the rise and subsequent decline in vitamin D levels were more pronounced. CONCLUSION: Effective vitamin D supplementation in healthy young adults can be achieved with a daily dose of 2,000 IU during winter. However, 4,000 IU/day was more effective for maintaining levels above 100 nmol/l, supporting broader health benefits. Regular monitoring of [25(OH)D], calcium, and phosphorus levels is essential.

• Klíčová slova
• Vitamin D, [25(OH)D)], supplementation, supplementation dose, supplementation safety, vitamin D deficiency,
• MeSH
• cholekalciferol * aplikace a dávkování   MeSH
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• nedostatek vitaminu D farmakoterapie   krev   MeSH
• pilotní projekty MeSH
• potravní doplňky * MeSH
• roční období MeSH
• vitamin D * aplikace a dávkování   krev   MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• zdraví dobrovolníci pro lékařské studie * MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Názvy látek
• cholekalciferol * MeSH
• vitamin D * MeSH

To evaluate vitamin D levels in children treated with fractures during the healing period. A four-year prospective study, including healthy children treated with diaphyseal fracture of femur or forearm bones. Vitamin D levels were examined four times: at the time of the injury and then one, three, and five months after the injury, together with P1NP, ALP, GGT, and parathormone. In the beginning, patients were blindly divided into two groups, one supplemented with vitamin D3 for the entire follow-up period, the other non-supplemented. Altogether, 107 children underwent examination at the time of their injuries. Of these, 63 were included in the study and examined for the entire follow-up period - 36 supplemented, 27 non-supplemented. At the time of injury, 42 % had a deficit of vitamin D, 36.5 % had insufficiency, only 21.5 % had normal levels. In the children supplemented with cholecalciferol, vitamin D levels increased statistically significantly during the follow-up period (already after 1 month), in contrast with non-supplemented patients, where they did not. When we divided patients according to the initial vitamin D levels (deficit/insufficiency/normal levels) or fracture type (femur/forearm), we also observed significantly better results in supplemented groups. We observed a high prevalence of vitamin D deficit or insufficiency in healthy children at the time of their injuries. Patients supplemented with vitamin D3 had normal levels already after one month and this persisted throughout the follow-up period, in contrast with non-supplemented patients. Therefore, we recommend vitamin D testing and administration for children treated for fractures. Keywords: Vitamin D, Pediatric fracture, Children, Vitamin D supplementation.

• MeSH
• cholekalciferol krev   terapeutické užití   MeSH
• dítě MeSH
• fraktury femuru krev   epidemiologie   MeSH
• hojení fraktur * účinky léků   MeSH
• lidé MeSH
• mladiství MeSH
• následné studie MeSH
• nedostatek vitaminu D * krev   epidemiologie   farmakoterapie   MeSH
• potravní doplňky MeSH
• předškolní dítě MeSH
• prospektivní studie MeSH
• vitamin D * krev   terapeutické užití   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• cholekalciferol MeSH
• vitamin D * MeSH

BACKGROUND/OBJECTIVE: Optimal vitamin D levels are required for bone health and proper functionality of the nervous, musculoskeletal and immune systems. The objective of this study was to assess the efficacy and safety profiles of new weekly calcifediol formulations with the potential to improve adherence and outcome. METHODS: A Phase II-III, double-blind, randomized, multicentre trial (EudraCT 2020-001099-14 and NCT04735926). Subjects were randomized 2:2:1 to calcifediol 75 µg, 100 µg and placebo. 25(OH)D levels were measured at 4, 16, 24, 32 and 52 weeks. The main outcome was the percentage of subjects who achieved a response defined as 25(OH)D levels ≥20 ng/mL and/or ≥30 ng/mL at week 16. RESULTS: 398 subjects (51.1 ± 15.96 years, 74.2% females, 98.7% Caucasian) with plasma 25(OH)D levels between 10 and 20 ng/mL were randomized. A total of 376 subjects completed 16 weeks of treatment, and 355 subjects completed the study. Six patients withdrew due to an adverse event, all unrelated to treatment. At week 16, 93.6% and 74.4% of subjects receiving calcifediol 75 µg achieved response levels of ≥20 ng/mL and ≥30 ng/mL, respectively. The calcifediol 100 µg group showed 98.7% and 89.9% of responders for ≥20 ng/mL and ≥30 ng/mL, respectively. Both calcifediol groups showed superiority over placebo at each response level at all time points analyzed (p < 0.0001). Calcifediol treatments increased 25(OH)D levels from baseline to week 24 and remained stable thereafter. The frequency of treatment-emergent adverse events was balanced between groups. CONCLUSIONS: New weekly calcifediol 75 and 100 µg formulations showed an effective and sustained response with a good long-term safety profile.

• Klíčová slova
• calcifediol, clinical trial, efficacy, phase II/III, safety, vitamin D deficiency, weekly,
• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• kalcifediol * krev   aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nedostatek vitaminu D * farmakoterapie   krev   MeSH
• potravní doplňky MeSH
• senioři MeSH
• vitamin D krev   analogy a deriváty   aplikace a dávkování   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• kalcifediol * MeSH
• vitamin D MeSH

Exercise-induced inflammation can influence iron metabolism. Conversely, the effects of vitamin D3, which possesses anti-inflammatory properties, on ultramarathon-induced heart damage and changes in iron metabolism have not been investigated. Thirty-five healthy long-distance semi-amateur runners were divided into two groups: one group received 150,000 IU of vitamin D3 24 h prior to a race (n = 16), while the other group received a placebo (n = 19). Serum iron, hepcidin (HPC), ferritin (FER), erythroferrone (ERFE), erythropoietin (EPO), neopterin (NPT), and cardiac troponin T (cTnT) levels were assessed. A considerable effect of ultramarathon running on all examined biochemical markers was observed, with a significant rise in serum levels of ERFE, EPO, HPC, NPT, and cTnT detected immediately post-race, irrespective of the group factor. Vitamin D3 supplementation showed a notable interaction with the UM, specifically in EPO and cTnT, with no other additional changes in the other analysed markers. In addition to the correlation between baseline FER and post-run ERFE, HPC was modified by vitamin D. The ultramarathon significantly influenced the EPO/ERFE/HPC axis; however, a single substantial dose of vitamin D3 had an effect only on EPO, which was associated with the lower heart damage marker cTnT after the run.

• Klíčová slova
• erythroferrone, erythropoietin, ferritin, iron, ultramarathon, vitamin D,
• MeSH
• biologické markery * krev   MeSH
• cholekalciferol * aplikace a dávkování   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• erythropoetin krev   aplikace a dávkování   MeSH
• hepcidiny krev   MeSH
• lidé středního věku MeSH
• lidé MeSH
• maratonský běh * fyziologie   MeSH
• nemoci srdce prevence a kontrola   etiologie   MeSH
• potravní doplňky * MeSH
• troponin T krev   MeSH
• železo * krev   aplikace a dávkování   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• biologické markery * MeSH
• cholekalciferol * MeSH
• erythropoetin MeSH
• hepcidiny MeSH
• troponin T MeSH
• železo * MeSH

Fat-soluble vitamin D is an essential bioactive compound important for human health. Insufficient vitamin D levels can result not only in bone disease but also in other disorders, such as cancer, metabolic disorders, and diseases related to poor immune function. The current methods commonly used for vitamin D analysis are often applied to determine the levels of the most abundant metabolite in plasma, i.e., 25-OH-D2/D3. These methods do not consider the presence of other hydroxylated and esterified metabolites, including isomers and epimers, which are typically found in low concentrations. In this study, we developed a fast and selective ultra-high performance supercritical fluid chromatography (UHPSFC) method using a 150 mm long 1-amino anthracene (1-AA) column and a mobile phase consisting of carbon dioxide and methanol/isopropanol (1/1, v/v) mixed with 8 % water. After thorough optimization of column temperature and back pressure, the separation of four vitamin D3 esters, vitamin D3 and D2, and eight mono- and di-hydroxylated metabolites, including three groups of isomers, was achieved in 10 min. Two ion sources, atmospheric pressure chemical ionization (APCI) and atmospheric pressure photoionization optimized within this study, were compared in tandem mass spectrometry (MS/MS) detection. No significant sensitivity differences were observed. Subsequently, the same 1-AA column chemistry was examined in ultra-high performance liquid chromatography (UHPLC) as the stationary phase that could hypothetically bring different selectivity in the separation of vitamin D and its metabolites. However, this hypothesis was rejected, and C18 was used as a stationary phase in the final optimized UHPLC-MS/MS method. Despite detailed optimization, the final 15 min UHPLC method was not able to separate di-hydroxylated isomers of vitamin D3, while it enabled better resolution of esterified forms compared to UHPSFC. Optimized methods provided similar repeatability of retention times and peak areas, with RSD < 2 % and 10 %, respectively. The lowest limits of quantification were in the range of 1.2 - 4.9 ng/mL for UHPSFC-APCI-MS/MS, while for UHPLC-APCI-MS/MS, they were typically in the range of 2.6 - 9.6 ng/mL. Based on the obtained results, the UHPSFC-APCI-MS/MS method was the most promising approach for fast, selective, and sensitive analysis that could be applied in the analysis of biological samples with emphasis on the separation of both hydroxylated and esterified metabolites, including isomeric forms.

• Klíčová slova
• Esters, Ion source, Mass spectrometry, Ultra high-performance liquid chromatography, Ultra high-performance supercritical fluid chromatography, Vitamin D,
• MeSH
• cholekalciferol MeSH
• lidé MeSH
• superkritická fluidní chromatografie * metody   MeSH
• tandemová hmotnostní spektrometrie metody   MeSH
• vitamin D * MeSH
• vitaminy MeSH
• vysokoúčinná kapalinová chromatografie metody   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• cholekalciferol MeSH
• vitamin D * MeSH
• vitaminy MeSH

BACKGROUND: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system. OBJECTIVES AND METHODS: A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8. RESULTS: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated. CONCLUSION: CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience.

• MeSH
• betamethason škodlivé účinky   MeSH
• dermatologické látky * škodlivé účinky   MeSH
• emoliencia terapeutické užití   MeSH
• fixní kombinace léků MeSH
• kalcitriol škodlivé účinky   MeSH
• lidé MeSH
• psoriáza * farmakoterapie   chemicky indukované   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• betamethason MeSH
• betamethasone-17,21-dipropionate MeSH Prohlížeč
• calcipotriene MeSH Prohlížeč
• dermatologické látky * MeSH
• emoliencia MeSH
• fixní kombinace léků MeSH
• kalcitriol MeSH

OBJECTIVES: The primary objective was to determine levels of C3-epi-25(OH)D in very low birth weight infants. The secondary objective was to evaluate the possible influence of preterm birth, intrauterine growth restriction (IUGR), and season of birth on the production of C3-epimers. METHODS: A total of 127 infants with birth weight less than 1,500 g met the inclusion criteria of the study. We examined 25-hydroxyvitamin-D [25(OH)D] levels and C3-epi-25(OH)D in maternal serum before labor, and in cord blood and infants' serum on days 14 and 28, and at discharge. RESULTS: The mean levels (±SD) of C3-epi-25(OH)D of the cord, on day 14, on day 28, and at discharge were 2.2 (2.9), 7.7 (5.5), 11.7 (7.6) and 14.9 (11.7) nmol/L respectively. The proportion of total 25(OH)D as the C3-epimer was 6.9% (cord), 16.3% (day 14), 22.4% (day 28) and 23.3% (discharge). A statistically significant correlation between 25(OH)D and C3-epi-25(OH)D can be demonstrated from birth. The severity of immaturity and IUGR did not affect the production of C3-epimers. In summer/autumn vs. winter/spring, the mean (SD) percentage of total 25(OH)D as the C3-epimer significantly differs only in maternal serum samples and umbilical cord samples (p value <0.001). CONCLUSIONS: The production of C3-epi-25(OH)D is functional even in the most immature newborns, has fetal origins, and is largely dependent on circulating 25(OH)D. At the end of the first month of life, C3-epimers make up more than 20% of 25(OH)D.

• Klíčová slova
• C3-epi-25(OH)D, C3-epimer, newborn, preterm infants, vitamin D,
• MeSH
• kalcifediol MeSH
• kojenec MeSH
• lidé MeSH
• nedostatek vitaminu D * MeSH
• novorozenec nedonošený MeSH
• novorozenec s velmi nízkou porodní hmotností MeSH
• novorozenec MeSH
• předčasný porod * MeSH
• vitamin D MeSH
• vitaminy MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• kalcifediol MeSH
• vitamin D MeSH
• vitaminy MeSH

OBJECTIVES: Although clinical research is still going on to determine any relationship between vitamin D and sleep regulation, only few studies have identified the role of vitamin D metabolism in sleep disorders. The current study aims to examine the incidence of vitamin D deficiency/insufficiency in the sample group and its effects on sleep quality and melatonin level. METHODS: A cross-sectional study was designed. A total of 79 women aged 18-49 years who applied to the research and training hospital between 1 October and 30 November 2021 participated in the study. Data were collected using a socio-demographic questionnaire prepared by the authors and the Pittsburgh Sleep Quality Index (PSQI). Blood samples were taken from the participants, also, 25-OH-vitamin D3 and melatonin levels in serum samples were measured by ELISA. RESULTS: The participants (n = 79) were aged 29.61 ± 11.14 years. The mean total PSQI scores of the participants were calculated as 5.77 ± 2.70. We determined that 64.6% of the participants had vitamin D deficiency, 21.5% had vitamin D insufficiency, and 13.9% of the participants were vitamin D sufficient. The mean melatonin level was found to be 24.77 ± 27.77 ng/L. We determined that an increase in the melatonin levels decreases the risk of vitamin D deficiency. Besides, our findings showed a good positive correlation between serum melatonin and 25 OH vitamin D3 levels (r = 0.544, p < 0.001). CONCLUSION: Our results indicate that the correction of vitamin D insufficiency can positively affect melatonin levels, therefore, it may positively contribute to the treatment of sleep disorders related to melatonin deficiency.

• Klíčová slova
• melatonin, sleep quality, vitamin D deficiency, woman,
• MeSH
• cholekalciferol MeSH
• lidé MeSH
• melatonin * MeSH
• nedostatek vitaminu D * epidemiologie   MeSH
• poruchy spánku a bdění * epidemiologie   komplikace   MeSH
• průřezové studie MeSH
• spánek fyziologie   MeSH
• vitamin D MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• cholekalciferol MeSH
• melatonin * MeSH
• vitamin D MeSH

The importance of vitamin D3 (hydroxycholecalciferol) as one of the liposoluble vitamins is known in the prevention and treatment of metabolic bone diseases (rickets, osteomalacia, osteoporosis). In recent years, however, information has increased on the importance of vitamin D3 in numerous organ systems and in the pathogenesis of various diseases, e. g. ophthalmopathies. The immunological functions of vitamin D3 are the subject of studies dealing with autoimmune optic nerve disorders and their results appear to have a positive effect on demyelinating diseases. It also plays an important role in maintaining the thickness of the retinal nerve fiber layer, but its additional administration has not been successful. Optical neuritis may be the first sign of multiple sclerosis. It appears that sufficient serum vitamin D3 levels may protect patients from deterioration in the form of a further attack of demyelination. The course of diabetic retinopathy is probably also influenced by vitamin D3, inter alia, by correlating the fact that its receptor and the enzymes of its metabolism are expressed on the retina. Low serum levels of vitamin D3 may even trigger age-related macular degeneration. Conversely, higher dietary intake of vitamin D3 may positively affect neovascularization. The optimal level of hydroxycholecalciferol is between 60 and 200 nmol /l, the severe deficit represents a decrease below 25 nmol/l. The body can normally produce up to 10,000 IU of this vitamin after exposure to sunlight. However, the demonstration of its protective character in connection with the mentioned diseases of the retina and optic nerve will require a sufficient number of studies to confirm the facts found so far about this rediscovered vitamin.

• Klíčová slova
• ophtalmopathias, vitamin, vitamin D,
• MeSH
• cholekalciferol metabolismus   MeSH
• hydroxycholekalciferoly MeSH
• lidé MeSH
• nedostatek vitaminu D * etiologie   prevence a kontrola   MeSH
• potravní doplňky MeSH
• vitamin D * metabolismus   MeSH
• vitaminy MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• cholekalciferol MeSH
• hydroxycholekalciferoly MeSH
• vitamin D * MeSH
• vitaminy MeSH