Chemicals and Drugs
Calcifediol
RayaldeeCalcidiolMetaboliteSerum 25OHDCholecalciferolPerson's vitaminSupplementationCalcitriolAdmissionCapsulesHospitalized COVID-19CohortDoseLiverOralSHPTComplicationsConcentrationsParicalcitolHypertensionClinical trialsMedicationSecondaryMortalityAntibiotic treatment2020InterventionPatientsExtended-releaseDietaryOutcomesDrugsLevelsMedicationsStudyDeficiencyWeeklyDaysEffectiveEffectsTimeReduce
Rayaldee7
  • In late November, OPKO announced that it was launching Rayaldee (calcifediol) extended-release capsules in the U.S. It was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2016. (biospace.com)
  • MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023. (opkorenal.com)
  • Eastern time on Friday, November 3, 2023 in Exhibit Halls B-D. The data demonstrate that effective control of SHPT has been achieved with RAYALDEE treatment in both randomized clinical trials and in a real-world clinical experience trial. (opkorenal.com)
  • Data from these trials support early initiation of SHPT treatment with RAYALDEE in order to delay disease progression. (opkorenal.com)
  • RAYALDEE is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. (opkorenal.com)
  • Slowing CKD progression with RAYALDEE treatment is not currently an approved indication. (opkorenal.com)
  • Our pharmaceutical business features Rayaldee ® (calcifediol), an FDA approved treatment for SHPT in stage 3-4 chronic kidney disease (CKD) patients with vitamin D insufficiency, which was launched in November 2016. (opko.com)
Calcidiol5
  • Calcifediol, also known as calcidiol, 25-hydroxycholecalciferol, or 25-hydroxyvitamin D3 (abbreviated 25(OH)D3), is a form of vitamin D produced in the liver by hydroxylation of vitamin D3 (cholecalciferol) by the enzyme vitamin D 25-hydroxylase. (wikipedia.org)
  • 2. in the liver it is hydroxylated to calcifediol, also called calcidiol or 25-hydroxyvitamin D (25OHD). (e-lactancia.org)
  • Collectively, the two forms together are referred to simply as 25-hydroxyvitamin D, also known as calcifediol or calcidiol. (creighton.edu)
  • Vitamin D is metabolized by the liver to 25(OH)D ( calcifediol , calcidiol, 25-hydroxycholecalciferol, or 25-hydroxyvitamin D), which is then converted by the kidneys to 1,25-dihydroxyvitamin D (1,25-dihydroxycholecalciferol, calcitriol , or active vitamin D hormone). (merckmanuals.com)
  • The vitamin D was provided as oral calcifediol, also known as calcidiol, 25(OH)D, and 25-hydroxyvitamin D. This is a metabolite of vitamin D that our livers make. (coachdenys.com)
Metabolite2
  • Calcifediol binds in the blood to vitamin D-binding protein (also known as gc-globulin) and is the main circulating vitamin D metabolite. (wikipedia.org)
  • Conclusion: Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. (influscience.eu)
Serum 25OHD3
  • Calcifediol can rapidly in- crease serum 25OHD concentration. (influscience.eu)
  • Demographical data, comorbidities, serum 25OHD levels and concomitant pharmacological treatments were collected as covariates. (bvsalud.org)
  • CONCLUSIONS: In this large, population-based study, we observed that patients supplemented with cholecalciferol or calcifediol achieving serum 25OHD levels ≥ 30 ng/ml were associated with better COVID-19 outcomes. (bvsalud.org)
Cholecalciferol8
  • Calcifediol is the precursor for calcitriol, the active form of vitamin D. It is synthesized in the liver, by hydroxylation of cholecalciferol (vitamin D3) at the 25-position. (wikipedia.org)
  • both forms are measured together in blood as 25(OH)D. At a typical intake of cholecalciferol (up to 2000 IU/day), conversion to calcifediol is rapid. (wikipedia.org)
  • The name 25(OH)D refers to any combination of calcifediol (25-hydroxy-cholecalciferol), derived from vitamin D3, and ercalcidiol (25-hydroxy-ergocalciferol), derived from vitamin D2. (wikipedia.org)
  • We investigate the effects of supplementation with cholecalciferol (D3) and calcifediol (25D3) on serum levels of 25(OH)D, 1-25(OH)D, bone and inflammatory markers, ultimately identifying clinical predictors of successful treatment. (unipg.it)
  • PURPOSE: To analyze the associations between cholecalciferol or calcifediol supplementation, serum 25-hydroxyvitamin D (25OHD) levels and COVID-19 outcomes in a large population. (bvsalud.org)
  • METHODS: All individuals ≥ 18 years old living in Barcelona-Central Catalonia (n = 4.6 million) supplemented with cholecalciferol or calcifediol from April 2019 to February 2020 were compared with propensity score-matched untreated controls. (bvsalud.org)
  • Associations between cholecalciferol or calcifediol use and outcome variables were analyzed using multivariate Cox proportional regression. (bvsalud.org)
  • When you are exposed to sunlight, your skin produces cholecalciferol, also known as vitamin D. This vitamin is then transported to the liver where it is converted into calcifediol. (discovermagazine.com)
Person's vitamin3
  • Measurement of serum calcifediol is the usual test performed to determine a person's vitamin D status, to show vitamin D deficiency or sufficiency. (wikipedia.org)
  • Our bodies convert both compounds to 1,25-dihydroxyvitamin D. Levels of 25-hydroxyergocalciferol and calcifediol in blood describe a person's vitamin D status. (cdc.gov)
  • Blood tests for assessing a person's vitamin D status measure two forms: 25-hydroxyergocalciferol (25-hydroxyvitamin D2) and calcifediol (25-hydroxyvitamin D3). (cdc.gov)
Supplementation2
  • This study aimed to determine the role of vitamin D supplementation in the prevention and treatment of SARS-CoV-2 infection through a meta-analysis of randomized controlled trials. (c19early.org)
  • Methods: The databases of PubMed, Cochrane Library, Embase, Web of Science and Google Scholar were searched systematically from inception to April 17,2023 to identify trials involving a randomized comparison of vitamin D supplementation versus non-vitamin D supplementation for SARS-CoV-2 infection prevention or treatment. (c19early.org)
Calcitriol5
  • Calcifediol can be further hydroxylated by the enzyme 25(OH)D-1α-hydroxylase, primarily in the kidney, to form calcitriol (1,25-(OH)2D3), which is the active hormonal form of vitamin D. Calcifediol is strongly bound in blood by the vitamin D-binding protein. (wikipedia.org)
  • Calcifediol is further hydroxylated at the 1-alpha-position in the kidneys to form 1,25-(OH)2D3, calcitriol. (wikipedia.org)
  • CYP27B1 is also expressed in a number of other tissues, including macrophages, monocytes, keratinocytes, placenta and parathyroid gland and extra-renal synthesis of calcitriol from calcifediol has been shown to have biological effects in these tissues. (wikipedia.org)
  • Calcitriol and other vitamin D metabolites are used in the treatment and prevention of Vit. (e-lactancia.org)
  • From the liver, calcifediol enters the bloodstream and is transported to the kidneys where it is turned into calcitriol. (discovermagazine.com)
Admission11
  • We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19. (influscience.eu)
  • Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. (influscience.eu)
  • Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. (influscience.eu)
  • Meta analysis and trial sequential analysis of 5 vitamin D RCTs, showing significantly lower mortality and ICU admission with treatment. (c19early.org)
  • But 50 patients regularly received oral Calcifediol until their discharge or admission to ICU. (easyhealthoptions.com)
  • Of the control group (the patients who did not receive calcifediol), 13 of the 26 progressed to disease level that required admission to ICU, where two subsequently died. (easyhealthoptions.com)
  • In the group getting Calcifediol, only one required admission to the ICU and there were no deaths in this group. (easyhealthoptions.com)
  • Logistic regression of calcifediol treatment on ICU admission, adjusted by age, gender, linearized 25(OH)D levels at baseline, and comorbidities showed that treated patients had a reduced risk to require ICU (RR 0.18). (aestheticsadvisor.com)
  • In the Intention-to-treat analysis, 36 (6.5%) out of 551 patients treated with calcifediol at admission died compared to 57 patients (15%) out of 379 controls. (aestheticsadvisor.com)
  • Interpretation: In patients hospitalized with COVID-19, calcifediol treatment at the time of hospitalization significantly reduced ICU admission and mortality. (aestheticsadvisor.com)
  • The treatment in this RCT was soft capsules of 532 mcg 25(OH)D on day 1 of admission to the hospital, followed by 266 mcg on days 3 and 7, and then 266 mcg once a week until discharge, ICU admission, or death. (coachdenys.com)
Capsules2
Hospitalized COVID-191
  • We conclude that the Córdoba study provides sufficient evidence to warrant immediate, well-designed pivotal clinical trials of calcifediol in a broader cohort of inpatients and outpatients with COVID-19, and to consider broad adoption of calcifediol treatment for vitamin-D-deficient hospitalized COVID-19 patients. (medrxiv.org)
Cohort1
  • Calcifediol use (n = 134,703) was not associated with reduced risk of SARS-CoV2 infection or mortality in the whole cohort. (bvsalud.org)
Dose3
  • Your doctor may increase or adjust your dose depending on your body's response to calcifediol. (medlineplus.gov)
  • High dose of calcifediol or 25-hydroxyvitamin D significantly reduced the need for ICU treatment of patients requiring hospitalization due to COVID-19. (naturalhealth24-7.com)
  • And a small, randomized study found that of 50 people hospitalized with COVID-19 who were given a high dose of a type of vitamin D (calcifediol), only one needed treatment in the intensive care unit. (peoplebeatingcancer.org)
Liver1
  • Calcifediol is also sometimes used to treat osteomalacia (weakening and softening of the bones) due to liver disease. (medlineplus.gov)
Oral3
  • Calcifediol is available as an oral medication in some countries to supplement vitamin D status. (wikipedia.org)
  • Oral formulations of calcifediol, solely indicated for treatment of renal secondary hyperparathyroidism are classified in H05BX - Other anti-parathyroid agents, while all other pharmaceutical formulations of calcifediol are classified in A11CC06. (whocc.no)
  • Treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease using controlled release, oral 25-hydroxyvitamin d. (medgend.com)
SHPT1
  • The drug was approved for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. (biospace.com)
Complications4
  • Of the patients treated with calcifediol, none died, and all were discharged, without complications. (influscience.eu)
  • Extensive research has explored the effects of vitamin D on the treatment and complications of COVID-19 and its potential contribution to the reduction of COVID-19 incidence. (kjccm.org)
  • Treatments can help with symptoms and complications. (medgend.com)
  • On the other hand, unnecessary treatment may lead to serious complications. (bvsalud.org)
Concentrations1
Paricalcitol3
  • Paricalcitol and doxercalciferol indicated for the prevention and treatment of secondary hyperparathyroidism are classified in H05BX - Other anti-parathyroid agents. (whocc.no)
  • Efecto regulador de paricalcitol sobre parámetros inflamatorios, fibróticos y anticalcificantes en el paciente con enfermedad renal crónica. (revistanefrologia.com)
  • Inflammation-fibrosis and calcification parameters showed positive regulation after paricalcitol treatment: interleukin-6 decreased significantly ( p = 0.001) and also TNF-α did ( p = 0.005), on the contrary, interleukin-10 and fetuin-A increased ( p = 0.001 for both). (revistanefrologia.com)
Hypertension1
  • Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). (influscience.eu)
Clinical trials1
  • His diagnosis was eventually pinned down as idiopathic multicentric Castleman disease, and he did identify a drug that could be repurposed to keep his disease at bay-an mTOR inhibitor-which is now in clinical trials for the treatment of idiopathic multicentric Castleman disease. (ascopost.com)
Medication1
Secondary2
  • These data will be presented in a poster, "Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression" (#TH-PO1152) at 10:00 a.m. (opkorenal.com)
  • The other poster, "Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism" (#FR-PO972), will be presented in the "CKD Interventions: Trials and Quality Improvement" session at 10:00 a.m. (opkorenal.com)
Mortality2
  • CONCLUSIONS: Combined treatment with corticosteroids and tocilizumab reduced mortality with about 25% in patients with severe COVID-19 pneumonia. (bvsalud.org)
  • Corticosteroids alone also resulted in lower in-hospital mortality rate compared to patients receiving only antiviral and antibiotic treatment. (bvsalud.org)
Antibiotic treatment1
  • This reduction appears to have real-world effects as a clinical trial of vitamin D combined with antibiotic treatment for tuberculosis resulted in a rapid drop of inflammation as compared with controls. (iherb.com)
20201
  • A landmark finding in the treatment of covid-19 was just published on Aug. 29, 2020. (coachdenys.com)
Intervention1
  • In particular, we show that decreased ICU admissions were not due to uneven distribution of comorbidities or other prognostic indicators, to imperfect blinding, or to chance, but were instead associated with the calcifediol intervention. (medrxiv.org)
Patients5
  • Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). (influscience.eu)
  • The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. (influscience.eu)
  • This project aims to develop new drugs based on vitamin D analogues for the treatment of vitamin D deficiency and its member pathologies, as well as to determine the modulatory role of calcifediol in the regulation of biomarkers in patients treated with vitamin D deficiency and cardiovascular disease. (basquehealthcluster.org)
  • The standard treatment all patients received included hydroxychloroquine and azithromycin. (easyhealthoptions.com)
  • These tests must be accurate to ensure correct diagnoses and treatment of patients with vitamin D deficiency. (cdc.gov)
Extended-release2
  • Calcifediol comes as an extended-release (long-acting) capsule to take by mouth. (medlineplus.gov)
  • One poster, "Extended-release Calcifediol Overcomes Impact of Low eGFR on Vitamin D Metabolism" (#FR-PO319), will be presented in the "Bone and Mineral Metabolism: Basic" session at 10:00 a.m. (opkorenal.com)
Dietary1
  • Diagnosis is typically based on elevated blood levels of 25(OH)D. Treatment consists of stopping vitamin D , restricting dietary calcium, restoring intravascular volume deficits, and, if toxicity is severe, giving corticosteroids or bisphosphonates. (merckmanuals.com)
Outcomes2
  • Calcifediol Treatment and COVID-19-Related Outcomes (SSRN Scholarly Paper ID 3771318). (hypothes.is)
  • Given the improvement in outcomes with immunosuppressive treatments, severe COVID-19 should fall into the category of cytokine storm," Dr. Fajgenbaum noted. (ascopost.com)
Drugs3
  • As of this writing , no drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, although several have received emergency use authorization and many others are being used off-label during the pandemic. (ascopost.com)
  • In addition to searching for novel therapies, David Fajgenbaum, MD, MBA, MSc, FCPP , and colleagues are pursuing whether repurposing available drugs may pay off as effective treatments to combat the pandemic. (ascopost.com)
  • Repurposed drugs identified by the CORONA Project as potential outpatient treatments include colchicine, inhaled budesonide, arbidol, fluvoxamine, and nitazoxanide. (ascopost.com)
Levels4
  • Variations in the expression and activity of CYP2R1, such as low levels in obesity, affect circulating calcifediol. (wikipedia.org)
  • tell your doctor if you are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly) or if you have or have ever had high blood levels of calcium. (medlineplus.gov)
  • If your levels are low, there are a few different treatment options available. (discovermagazine.com)
  • Strong CYP3A4 inducers can reduce panobinostat levels by ~70% and lead to treatment failure. (medscape.com)
Medications3
  • Calcifediol is in a class of medications called vitamin D analogs. (medlineplus.gov)
  • Many other medications may also interact with calcifediol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. (medlineplus.gov)
  • Treatment to increase calcium excretion and reduce bone resorption of calcium involves saline, sodium diuresis, and medications such as those used for treatment of seizure disorders. (msdmanuals.com)
Study1
  • The goal of that study is to compare weekly treatment with hGH-CTP against daily injections of Genotropin. (biospace.com)
Deficiency3
  • Is long-term treatment with pegylated GH a safe and effective option for pediatric GH deficiency? (medscape.com)
  • PURPOSE: Growth hormone deficiency (GHD) must be confirmed before starting treatment in adults with Prader-Willi syndrome (PWS). (bvsalud.org)
  • The experience of the member of the Basque Health Cluster in the treatment of vitamin D deficiency is extensive and its intention is to continue to deepen the knowledge of this molecule. (basquehealthcluster.org)
Weekly1
Days1
  • Calcifediol has an elimination half-life of around 15 to 30 days. (wikipedia.org)
Effective1
  • This happened several times, and no treatments were effective. (ascopost.com)
Effects1
Time1
Reduce1
  • Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer. (influscience.eu)