Clinical trial NCT04735926: Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitamin D Deficiency
Vitamin D Insufficiency
Keywords: Vitamin D deficiency
Hypovitaminosis D
Vitamin D Insufficiency
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sevlievo
country: Bulgaria
facility: MC-1-Sevlievo Ltd.
city: Sofia
country: Bulgaria
facility: Diagnostic & Consultative Center "Sveta Anna" EOOD
city: Sofia
country: Bulgaria
facility: Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology
city: Sofia
country: Bulgaria
facility: IV MHAT - Sofia
city: Sofia
country: Bulgaria
facility: Lora - Medical center Sofia
city: Sofia
country: Bulgaria
facility: Medical Centre Asklepion - Research in human medicine
city: Sofia
country: Bulgaria
facility: Medical Centre Salvebis
city: Brno
country: Czechia
facility: Alergologie Němcová, s.r.o.
city: Choceň
country: Czechia
facility: Poliklinika Choceň - Neurologická ambulance
city: Hradec Králové
country: Czechia
facility: MUDr. Eva Richterová - HK, s.r.o.
city: Krnov
country: Czechia
facility: MUDr. Tomáš Edelsberger
city: Olomouc
country: Czechia
facility: G-CENTRUM Olomouc s.r.o.
city: Praha
country: Czechia
facility: Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze
city: Praha
country: Czechia
facility: MediCel, s.r.o.
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o.
city: Praha
country: Czechia
facility: RS centrum - Neurologická klinika 1.LF UK a VFN v Praze
city: Písek
country: Czechia
facility: Centrum gynekologické rehabilitace s.r.o.
city: Teplice
country: Czechia
facility: Ordinace MediFem, s.r.o.
city: Bordeaux
country: France
facility: CHU Bordeaux, Hôpital Pellegrin
city: Orléans
country: France
facility: CHR Orléans, Service Rhumatologie
city: Saint-Étienne
country: France
facility: CHU Saint Etienne, Hôpital Nord
city: Toulouse
country: France
facility: CHU Purpan
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele /Unità di Endocrinologia
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione
city: Palermo
country: Italy
facility: UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo
city: Pisa
country: Italy
facility: AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
city: Roma
country: Italy
facility: Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia
city: Belgrade
country: Serbia
facility: Institut za reumatologiju
city: Kragujevac
country: Serbia
facility: Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju
city: Niška Banja
country: Serbia
facility: Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju
city: Novi Sad
country: Serbia
facility: Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma
city: Novi Sad
country: Serbia
facility: Specijalna bolnica za reumatske bolesti Novi Sad
city: Zrenjanin
country: Serbia
facility: Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju
city: Bardejov
country: Slovakia
facility: IN MEDIC s.r.o., Neurologická ambulancia
city: Komárno
country: Slovakia
facility: ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie
city: Košice
country: Slovakia
facility: ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie
city: Košice
country: Slovakia
facility: Endomed, s.r.o. - Gastroenterologická ambulancia
city: Levice
country: Slovakia
facility: DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie
city: Lučenec
country: Slovakia
facility: KARDIO 1, s.r.o., Kardiologická ambulancia
city: Rimavská Sobota
country: Slovakia
facility: Elte HU, s.r.o., Chirurgická ambulancia
city: Rimavská Sobota
country: Slovakia
facility: Kardioamb, s.r.o., Kardiologická a interná ambulancia
city: Rimavská Sobota
country: Slovakia
facility: MEDILEX, s.r.o., Ambulancia vnútorného lekárstva
city: Rimavská Sobota
country: Slovakia
facility: Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie
city: Spišská Nová Ves
country: Slovakia
facility: Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia
city: Topoľčany
country: Slovakia
facility: ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie
city: Žilina
country: Slovakia
facility: KK Neuro, s.r.o., Neurologická ambulancia
city: Barcelona
country: Spain
facility: Clínica Sagrada Familia
city: Barcelona
country: Spain
facility: EAP Sardenya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Quirónsalud Barcelona
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
References: