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.
- 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
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.
- 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
Vztah složení naší stravy a vzniku a léčby diabetes mellitus 1. typu (DM1) je znám již od dob před objevením inzulinu, kdy se poprvé objevila snaha pomocí dietních opatření zpomalit či zastavit progresi onemocnění. Kromě toho je k dietě přistupováno i jako k doplňkové léčbě k inzulinoterapii, jejímž účelem má být snaha o dosažení terapeutických cílů. V rámci dietních opatření v souvislosti s DM1 byl dosud zejména zkoumán vliv umělé dětské výživy, lepku, respektive jeho vysazení, vitaminu D, omega-3 mastných kyselin a sníženého příjmu sacharidů v rámci takzvané nízkosacharidové diety. Cílem tohoto přehledového článku je uceleně shrnout nejnovější vědecké poznatky o nutričních intervencích v různých fázích DM1.
Nutrition and type 1 diabetes (T1D) have been closely linked even before the discovery of insulin where the dietary interventions have been part of the effort to prevent or slow the progression of the disease. Additionally, alternative dietary approaches are sought as an adjuvant therapy to insulin use. The focus is given to these dietary approaches – infant formula, gluten and its exclusion, vitamin D, omega-3 fatty acids and limiting of the carbohydrate intake. The aim of this review is to summarize the scientific knowledge regarding dietary interventions in different stages of T1D.
- MeSH
- bezlepková dieta klasifikace metody MeSH
- diabetes mellitus 1. typu * diagnóza dietoterapie imunologie MeSH
- dieta s omezením sacharidů klasifikace metody MeSH
- dietoterapie * klasifikace metody MeSH
- dítě MeSH
- kalcitriol terapeutické užití MeSH
- kojenec MeSH
- lidé MeSH
- omega-3 mastné kyseliny terapeutické užití MeSH
- strava, jídlo, výživa MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- Publikační typ
- přehledy MeSH
Role vitaminu D je klasicky spojována především s kalcium-fosfátovým metabolismem. V posledních letech však máme stále více informací o jeho významném imunoregulačním vlivu, a to jak na vrozenou, tak adaptivní imunitu. Vitamin D má svůj význam při ochraně před patogenními mikroorganismy i v udržení imunotolerance a jeho nedostatek bývá spojován s infekcemi, autoimunitními či nádorovými chorobami.
Vitamin D is associated primarily with calcium-phosphate metabolism. However, in recent years we have many studies demontrating its significant immunoregulatory effect, both on innate and adaptive immunity. Vitamin D is important in protection against pathogenic microorganisms and in maintaining immunotolerance, and its deficiency is assumed to be associated with infections, autoimmune or cancer diseases.
- MeSH
- adaptivní imunita fyziologie MeSH
- imunomodulace * fyziologie MeSH
- kalcitriol analýza fyziologie imunologie MeSH
- lidé MeSH
- lymfocyty fyziologie imunologie MeSH
- nedostatek vitaminu D imunologie MeSH
- přirozená imunita fyziologie MeSH
- vitamin D * analýza fyziologie imunologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy 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 TechnologyTM, 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
Objectives: The goal of this study was to see how systemic vitamin D3 supplementation affected the durability of dental implants as assessed by radiofrequency analysis.Methods: This split-mouth clinical trial included a total of twelve patients seeking dental implant therapy, ranging in age from 25 to 50 years. The patients were divided into control group and treatment group. Each patient in both groups received dental implants in posterior maxillary extraction sites. The radiofrequency analysis (RFA) was conducted using Osstell Mentor device to evaluate the stability of dental implant at various time points.Results: During the three months of the trial, substantial differences between the treatment and control groups were detected according to osstell meter device at the time of insertion (primary stability) and 3 months later (secondary stability).Conclusion: Vitamin D supplementation has a positive effect on dental implant stability.
- MeSH
- dítě MeSH
- kalcitriol krev metabolismus MeSH
- lidé MeSH
- nedostatek vitaminu D komplikace prevence a kontrola MeSH
- randomizované kontrolované studie jako téma MeSH
- rozvrh dávkování léků MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- vápník metabolismus MeSH
- vitamin D * analýza metabolismus terapeutické užití MeSH
- Check Tag
- dítě MeSH
- lidé 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.
- 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
Vitamin D is no longer considered an agent only affecting calcium phosphate metabolism. A number of studies over the past few years have demonstrated its role in immunomodulation and its influence on the development and functioning of the brain and nervous system. In the current epidemiological crisis caused by coronavirus disease 2019 (COVID-19), the immunoprotective role of vitamin D has been discussed by some authors regarding whether it contributes to protection against this serious disease or whether its use does not play a role. Non-standard approaches taken by laboratories in examining the serum levels of the vitamin D metabolite calcidiol have contributed to inconsistent results. We examined the serum of 60 volunteers in the spring and autumn of 2021 who declared whether they were taking vitamin D at the time of sampling. Furthermore, the tested participants noted whether they had experienced COVID-19. A newly developed liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to measure calcidiol levels. The analysis of variance (ANOVA) model of Statgraphics Centurion 18 statistical software from Statgraphics Technologies was used for calculations. The results of this study showed that those who took vitamin D suffered significantly less often from COVID-19 than those who did not take vitamin D.
