Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 µg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial.
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 adh...
| Publicado en: | Nutrients Vol. 16; no. 22; pp. 3796 - 3810 |
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| Autores principales: | , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
MDPI
Nov2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=181204543&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 181204543 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 20726643 B0TT jtl: Nutrients issn: 20726643 maglogo: N pubinfo: dt: Nov2024 vid: 16 iid: 22 pid: 97109 pub: MDPI artinfo: ui: 181204543 181204543 181204543 10.3390/nu16223796 181204543 ppf: 3796 ppct: 14 formats: tig: atl: Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 µg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial. aug: au: Jódar-Gimeno, Esteban Pérez-Castrillón, Jose Luis Nociar, Ján Lojka, Michal Nikolov, Dimitar Cereto-Castro, Fernando Novković, Snežana Tarantino, Umberto Mehsen-Cetre, Nadia Arranz, Paula Ostalé, Cristina Martínez García-Bea, Aintzane Gilaberte, Inmaculada affil: Department of Endocrinology and Nutrition, Quirónsalud Madrid University Hospital, 28223 Madrid, Spain sug: subj: Vitamin D Deficiency Drug Therapy Vitamin D Therapeutic Use Vitamin D Administration and Dosage Drug Efficacy Evaluation Patient Safety Evaluation Treatment Duration Medication Compliance Treatment Outcomes Human Female Male Adult Middle Age Aged Randomized Controlled Trials Random Assignment Control Group Multicenter Studies Double-Blind Studies Placebos Vitamin D Blood Comparative Studies Descriptive Statistics Funding Source Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Female Male ab: 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. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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