Vitamin D Deficiency Clinical Trial
— WORFEROLOfficial title:
Randomised, Double-blind, Double-dummy, Multicentre Trial to Evaluate the Efficacy and Safety of Three Different Weekly Dosages of Calcifediol Versus Placebo in Subjects With Either Vitamin D Deficiency or Insufficiency.
Verified date | September 2023 |
Source | Faes Farma, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.
Status | Completed |
Enrollment | 674 |
Est. completion date | April 25, 2023 |
Est. primary completion date | July 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female subjects = 18 years of age. - Evidence of serum 25-OH-D levels < 20 ng/mL or = 10 ng/mL, for each cohort. - Written informed consent. - For females of childbearing potential only: willing to perform pregnancy tests, must agree to use highly effective methods of birth control throughout the study. Exclusion Criteria: - Subjects receiving any treatment with calcifediol, vitamin D analogues, vitamin complexes or vitamin D supplements. - Subjects taking drugs that could modify vitamin D levels. - Subjects taking calcium supplements. - Uncorrected hypercalcaemia, known hypercalciuria or nephrolithiasis. - Severe renal impairment. - Subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypothyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism. - Any present or previous malignancy. - Known contraindications or sensitivities to the use of the IP or any of its components. - Pregnant woman, breastfeeding woman or woman planning a pregnancy. - Subject has received an IP within 30 days before the start of the screening or is currently enrolled in an investigational interventional study. - Any condition that may jeopardise the clinical trial conduct according to the protocol. - Employees of the investigator or clinical trial site, as well as family members of the employees or the principal investigator. - Person committed to an institution by virtue of an order issued either by judicial or other authorities. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | MC-1-Sevlievo Ltd. | Sevlievo | |
Bulgaria | Diagnostic & Consultative Center "Sveta Anna" EOOD | Sofia | |
Bulgaria | Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology | Sofia | |
Bulgaria | IV MHAT - Sofia | Sofia | |
Bulgaria | Lora - Medical center Sofia | Sofia | |
Bulgaria | Medical Centre Asklepion - Research in human medicine | Sofia | |
Bulgaria | Medical Centre Salvebis | Sofia | |
Czechia | Alergologie Nemcová, s.r.o. | Brno | |
Czechia | Poliklinika Chocen - Neurologická ambulance | Chocen | |
Czechia | MUDr. Eva Richterová - HK, s.r.o. | Hradec Králové | |
Czechia | MUDr. Tomáš Edelsberger | Krnov | |
Czechia | G-CENTRUM Olomouc s.r.o. | Olomouc | |
Czechia | Centrum gynekologické rehabilitace s.r.o. | Písek | |
Czechia | Centrum pro diagnostiku a lécbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze | Praha | |
Czechia | MediCel, s.r.o. | Praha | |
Czechia | Milan Kvapil s.r.o. | Praha | |
Czechia | RS centrum - Neurologická klinika 1.LF UK a VFN v Praze | Praha | |
Czechia | Ordinace MediFem, s.r.o. | Teplice | |
France | CHU Bordeaux, Hôpital Pellegrin | Bordeaux | |
France | CHR Orléans, Service Rhumatologie | Orléans | |
France | CHU Saint Etienne, Hôpital Nord | Saint-Étienne | |
France | CHU Purpan | Toulouse | |
Italy | Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche | Milano | |
Italy | IRCCS Ospedale San Raffaele /Unità di Endocrinologia | Milano | |
Italy | Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione | Napoli | |
Italy | UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo | Palermo | |
Italy | AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci | Pisa | |
Italy | Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia | Roma | |
Serbia | Institut za reumatologiju | Belgrade | |
Serbia | Klinicki centar Kragujevac, Centar za reumatologiju, alergologiju i klinicku imunologiju, Odeljenje za reumatologiju | Kragujevac | |
Serbia | Institut za lecenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju | Niška Banja | |
Serbia | Klinicki centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma | Novi Sad | |
Serbia | Specijalna bolnica za reumatske bolesti Novi Sad | Novi Sad | |
Serbia | Opšta bolnica "Ðorde Joanovic" Zrenjanin, Odeljenje za reumatologiju | Zrenjanin | |
Slovakia | KK Neuro, s.r.o., Neurologická ambulancia | Žilina | |
Slovakia | IN MEDIC s.r.o., Neurologická ambulancia | Bardejov | |
Slovakia | ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie | Košice | |
Slovakia | Endomed, s.r.o. - Gastroenterologická ambulancia | Košice | |
Slovakia | ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie | Komárno | |
Slovakia | DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie | Levice | |
Slovakia | KARDIO 1, s.r.o., Kardiologická ambulancia | Lucenec | |
Slovakia | Elte HU, s.r.o., Chirurgická ambulancia | Rimavská Sobota | |
Slovakia | Kardioamb, s.r.o., Kardiologická a interná ambulancia | Rimavská Sobota | |
Slovakia | MEDILEX, s.r.o., Ambulancia vnútorného lekárstva | Rimavská Sobota | |
Slovakia | Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie | Rimavská Sobota | |
Slovakia | Plúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia | Spišská Nová Ves | |
Slovakia | ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie | Topolcany | |
Spain | Clínica Sagrada Familia | Barcelona | |
Spain | EAP Sardenya | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Quirónsalud Barcelona | Barcelona | |
Spain | Hospital Universitario Quirónsalud Madrid | Pozuelo De Alarcón | |
Spain | Complejo Asistencial Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
Spain | Hospital Universitario Rio Hortega | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Faes Farma, S.A. |
Bulgaria, Czechia, France, Italy, Serbia, Slovakia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess efficacy for each cohort in terms of percentage of subjects achieving 25-OH-D levels = 30 ng/mL and/or = 20 ng/mL at 16 weeks of treatment. | Percentage of subjects who achieve 25-OH-D levels = 30 ng/mL and/or = 20 ng/mL | 16 weeks |
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