calcifediol / Generic mfg. - LARVOL DELTA

Single-dose Pharmacokinetics of Extended-release Calcifediol in Healthy Japanese and non-Japanese Volunteers (ERA 2025) - "No racial differences in PK profiles of serum calcifediol and its primary vitamin D metabolites (24,25D 3 and 1,25D) were observed between Japanese and non-Japanese participants after single doses of oral ERC in fasting and fed conditions."

Clinical • PK/PD data • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Calcitriol and Calcifediol Mediate Oxidative Stress-induced Apoptosis in HeLa Cervical Cancer Cells (ENDO 2025) - "These findings support ROS-mediated induction of intrinsic apoptosis at supraphysiological doses of 25(OH)D₃ and calcipotriol in HeLa. Current work is underway to analyse the antioxidant defence system and regulation of ROS-activated intracellular cascades in HeLa."

Oxidative stress • Cervical Cancer • Oncology • Solid Tumor • ANXA5 • CASP3 • CASP7

COVIDIOL: Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19). (clinicaltrials.gov) - P=N/A | N=230 | Completed | Sponsor: Complejo Hospitalario Universitario de Albacete | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Extended-Release Calcifediol Normalized 1,25-Dihydroxyvitamin D and Prevented Progression of Secondary Hyperparathyroidism in Hemodialysis Patients in a Randomized Clinical Trial. (PubMed, Am J Nephrol) - "ERC safely raised serum total 25D, normalized low serum 1,25D and stabilized elevated plasma iPTH in this pilot placebo-controlled RCT involving ESKD patients requiring regular HD. The observed increases in 1,25D indicated that ERC restored adequate endogenous vitamin D hormone production via substrate-driven conversion to calcitriol in extra-renal tissues expressing CYP27B1, thereby preventing SHPT progression."

Clinical • Journal • Chronic Kidney Disease • Endocrine Disorders • Metabolic Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Effectiveness of supplementation with different doses of calcifediol in HIV patients with vitamin D deficiency. (PubMed, Enferm Infecc Microbiol Clin (Engl Ed)) - "The regimen of 16,000IU calcifediol weekly for 12 weeks followed by biweekly dosing is both safe and effective for PWH, significantly increasing vitamin D levels and improving the CD4:CD8 ratio without adverse effects."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

A Scoping Review of Vitamins Detection Using Electrochemically Polymerised, Molecularly Imprinted Polymers. (PubMed, Polymers (Basel)) - "The resulting 12 articles covered the detection of vitamins in ascorbic acid, riboflavin, cholecalciferol, calcifediol, and menadione using monomers of catechol (CAT), 3,4-ethylenedioxythiophene (EDOT), o-aminophenol (oAP), o-phenylenediamine (oPD), pyrrole, p-aminophenol (pAP), p-phenylenediamine (pPD), or resorcinol (RES), using common bare electrodes including graphite rod electrode (GRE), glassy carbon electrode (GCE), gold electrode (GE), and screen-printed carbon electrode (SPCE)...However, more discoveries and development of detection methods needs to be performed, especially for the vitamins that have not been studied yet. This will allow the improvement in the application of eMIPs on portable-based detection and POCT devices."

Journal • Review

Analysis of the Efficacy and Safety of Weekly Calcifediol 100 µg in Vitamin D Deficient Patients. (PubMed, J Clin Med) - "The frequency of treatment-emergent adverse events was similar in both groups, placebo and calcifediol. Weekly supplementation of 100 μg calcifediol effectively restores vitamin D levels in individuals with both mild and severe deficiencies, demonstrating a favourable safety profile."

Clinical • Journal

Development of Highly Sensitive and Specific and Genetically Encoded Biosensors for Calcifediol and Calcitriol Detection. (PubMed, ACS Sens) - "The biosensors demonstrated high accuracy in measuring calcifediol in dietary supplements and calcitriol in pharmaceutical formulations, showing strong concordance with HPLC results. These findings suggest that the proposed biosensors may provide a cost-effective, rapid, and reliable alternative for food safety inspection and clinical diagnostics."

Journal

Vitamin D3 loaded polycaprolactone nanoparticles enhance the expression of the antimicrobial peptide cathelicidin in macrophages. (PubMed, Artif Cells Nanomed Biotechnol) - "Encapsulated calcifediol and calcitriol (100 ng/ml) induced the expression of 243.46 ng/ml ± 4.55 ng/ml and 396.67 ng/ml ± 25.24 ng/ml of cathelicidin, respectively, which was significantly higher than that induced by the free drugs. These findings suggest that NP encapsulation may offer a more efficient approach to using vitamin D3 for inducing cathelicidin expression as a host-directed treatment for TB."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy of Oral Supplementation with Cholecalciferol Versus Calcifediol in Patients with Hypovitaminosis D After Stroke. (PubMed, Nutrients) - "These results highlight the importance of further investigating bone metabolism in post-stroke patients, though findings should be confirmed in larger studies."

Clinical • Journal • Observational data • Retrospective data • Cardiovascular • Osteoporosis • Rheumatology

Effect of calcifediol and cholecalciferol on muscle function in postmenopausal women: a randomized controlled trial. (PubMed, Osteoporos Int) - P2 | "Our findings do not support supplementation with daily calcifediol or equivalent high-dose daily vitamin D3 for improving or maintaining lower extremity function among younger postmenopausal women (age 50-70) with osteopenia or osteoporosis, who were pre-selected for vitamin D insufficiency or deficiency (25(OH)D < 30 ng/mL; baseline mean 25(OH)D 23.4 ng/mL)."

Journal • Osteoporosis • Rheumatology

Redesigning CYP109E1 for Improving Catalytic Performance in 25-Hydroxyvitamin D3 Synthesis Through Synergistic Enhancement of Electron Transfer and NADPH Regeneration. (PubMed, ACS Synth Biol) - "Finally, an NADPH regeneration system was introduced by overexpressing zwf, which increased the yield of 25(OH)VD3 48.7%. These results demonstrate that recombinant Escherichia coli BL21 (DE3) coexpressing CYP109E1_R70A-ZWF and 2Adx4-108T69Es-Fpr is an efficient whole-cell biocatalyst for the synthesis of 25(OH)VD3, illustrating an attractive strategy for improving the catalytic efficiency of P450 enzymes."

Journal

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI (clinicaltrials.gov) - P2 | N=44 | Terminated | Sponsor: OPKO Health, Inc. | N=256 ➔ 44 | Active, not recruiting ➔ Terminated; Cohort 1 completed and cohort 2 terminated prior to initiation per company decision

Enrollment change • Trial termination • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Determining correlation between changes in blood pressure and vitamin D levels: Analyzing influencing factors in hypertensive adults at Family Medicine Clinics. (PubMed, J Family Med Prim Care) - "Pakistan faces significant hypertension and vitamin D deficiency burdens. Our study found a potential link between varying vitamin D levels and blood pressure fluctuations in hypertensive patients, warranting further research."

Journal • Cardiovascular • Genetic Disorders • Hypertension • Obesity

Vitamin D: are all compounds equal? (PubMed, Clin Kidney J) - "This review aims to provide a comprehensive overview of vitamin D, including its natural sources and metabolism, and examines the main available pharmacological vitamin D products. Particular emphasis is placed on their application in CKD management, highlighting how these compounds can be strategically used to address both vitamin D deficiency and secondary hyperparathyroidism, while also acknowledging the ongoing debate about their impact on bone health and other clinical outcomes."

Journal • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism

Retrospective real world study on vitamin D supplementation: Looking for the most effective molecule and its frequency of use. (PubMed, Clin Nutr) - "Pre-treatment serum 25(OH)D levels are valuable for selecting patients who should undergo supplementation. This finding suggests the importance of tailoring therapy according to the degree of vitamin D deficiency."

Journal • Real-world evidence • Retrospective data

Dose titration with extended-release calcifediol (ERC) improves intact parathyroid hormone (iPTH) control in chronic kidney disease (CKD) patients. (NKF-SCM 2025) - "Ninety-five participants titrated to a maintenance dose of 60 μg/day and 86% of them reached the 25D target. Dose titration did not increase Ca, P, FGF23, or rates of adverse events.Conclusion Dose titration to a maintenance dose of 60 μg/day during long-term treatment with ERC was safe and increased the likelihood of achieving serum 25D levels of ≥50 ng/mL (despite obesity) and sustained reductions in plasma iPTH of ≥30%, the latter being associated with slower rates of eGFR decline in patients with SHPT and stage 3-4 CKD."

Clinical • Chronic Kidney Disease • Endocrine Disorders • Genetic Disorders • Nephrology • Obesity • Renal Disease • Secondary Hyperparathyroidism • FGF23

A Randomized Phase II/III Trial Evaluating the Efficacy and Safety of 100 and 125 µg of Calcifediol Weekly Treatment of Severe Vitamin D Deficiency. (PubMed, Nutrients) - "The incidence of adverse events was comparable across groups. 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."

Clinical • Journal • P2/3 data

Adjunctive active vitamin D (AVD) decreases kidney function during treatment of secondary hyperparathyroidism (SHPT) with extended-release calcifediol (ERC) in non-dialysis chronic kidney disease (ND-CKD). (PubMed, Am J Nephrol) - "Adj AVD at these doses enabled 35% more iPTH reduction in ND-CKD patients with mild to moderate SHPT on long-term ERC treatment but increased mean serum Ca and P by 0.40 and 0.27 mg/dL, respectively, FGF23 by more than 2-fold and eGFR decline by 4-fold, suggesting that adding AVD to ERC has untoward effects that override the nephrosparing impact of iPTH reductions with ERC treatment alone. Corroboration is warranted with a larger, longer RCT."

Journal • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism • FGF23

Vitamin D Deficiency Meets Hill's Criteria for Causation in SARS-CoV-2 Susceptibility, Complications, and Mortality: A Systematic Review. (PubMed, Nutrients) - "Clinical trials consistently demonstrate an inverse correlation between serum 25-hydroxyvitamin D [25(OH)D; calcifediol] levels and the risk of symptomatic SARS-CoV-2 disease, complications, and mortality...When serum 25(OH)D levels exceed 70 ng/mL, taking vitamin K2 (100 µg/day or 800 µg/week) alongside vitamin D helps direct any excess calcium to bones. The recommended vitamin D dosage (approximately 70 IU/kg of body weight for a non-obese adult) to maintain 25(OH)D levels between 50-100 ng/mL is safe and cost-effective for disease prevention, ensuring optimal health outcomes."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Obesity • Respiratory Diseases

A narrative review focusing on randomized clinical trials of vitamin D supplementation for COVID-19 disease. (PubMed, Front Nutr) - "To better understand and look into the issue, we went through the background knowledge of COVID-19 and vitamin D, searched in Pubmed [by using key words in the title containing "randomized clinical trial", "COVID-19", and "vitamin D (25-hydroxyvitamin D, or cholecalciferol, or calcidiol, or calcifediol) supplementation"] for publications of studies on vitamin D/supplementation in COVID-19 patients, especially those about the randomized clinical trials (RCTs). After reviewing these papers, we did a short background review of vitamin D and the pathophysiology of COVID-19, summarized the key features of the 25 RCTs in text and tabulated in a table of some of the features, commented, compared and discussed the differences between RCTs (for example, change the serum 25-hydroxyvitamin D concentration from nmol/L to ng/mL, making the comparison easier). The take-home question of the review is that serum 25-hydroxyvitamin D concentration is an..."

Clinical • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A comparative study on the antioxidant and antiglycation properties of different vitamin D forms. (PubMed, Eur J Med Chem) - "Our study focused on the antioxidant and antiglycation properties of the four primary forms of vitamin D such as cholecalciferol, calcifediol, alfacalcidol, and calcitriol...The pleiotropic action of vitamin D, especially calcitriol, may indicate a high therapeutic potential of vitamin D supplementation in various diseases with carbonyl stress etiology. Further research is needed to fully understand the underlying mechanisms of vitamin D pleiotropic effects and determine the optimal dosages for clinical use."

Journal

Calcifediol and paricalcitol as adjunctive therapies for HSV-1 keratitis and corneal perforation: A case report. (PubMed, Medicine (Baltimore)) - "Corneal stabilization avoided a high-risk, full-thickness corneal transplantation, facilitating future cataract surgery, and allowing for some degree of visual recovery in this eye."

Journal • Cataract • Corneal Abrasion • Herpes Simplex • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pain • Transplantation

Integrating Endocrine, Genomic, and Extra-Skeletal Benefits of Vitamin D into National and Regional Clinical Guidelines. (PubMed, Nutrients) - "This review and its recommendations address the gaps in current vitamin D clinical practice guidelines and propose a framework for developing more effective, country and region-specific recommendations that capture the extra-skeletal benefits of vitamin D to prevent multiple diseases and enhance public health."

Clinical • Clinical guideline • Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Immunology • Infectious Disease • Metabolic Disorders • Obesity • Osteoporosis • Rheumatology

Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 µg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial. (PubMed, Nutrients) - P2/3 | "New weekly calcifediol 75 and 100 µg formulations showed an effective and sustained response with a good long-term safety profile."

Clinical • Journal • P2/3 data • Musculoskeletal Diseases