Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

674

Participants

Timeline

Start Date

December 23, 2020

Primary Completion Date

July 21, 2022

Study Completion Date

April 25, 2023

Conditions
Vitamin D DeficiencyVitamin D Insufficiency
Interventions
DRUG

Calcifediol 75mcg

Soft gelatin capsule. Oral administration once per week

DRUG

Calcifediol 100mcg

Soft gelatin capsule. Oral administration once per week

DRUG

Calcifediol 125mcg

Soft gelatin capsule. Oral administration once per week.

OTHER

Placebo

Soft gelatin capsule. Oral administration once per week.

OTHER

Placebo

Soft gelatin capsule. Oral administration once per week.

Trial Locations (55)

Unknown

MC-1-Sevlievo Ltd., Sevlievo

"Diagnostic & Consultative Center Sveta Anna EOOD", Sofia

Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology, Sofia

IV MHAT - Sofia, Sofia

Lora - Medical center Sofia, Sofia

Medical Centre Asklepion - Research in human medicine, Sofia

Medical Centre Salvebis, Sofia

Alergologie Němcová, s.r.o., Brno

Poliklinika Choceň - Neurologická ambulance, Choceň

MUDr. Eva Richterová - HK, s.r.o., Hradec Králové

MUDr. Tomáš Edelsberger, Krnov

G-CENTRUM Olomouc s.r.o., Olomouc

Centrum gynekologické rehabilitace s.r.o., Písek

Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze, Prague

MediCel, s.r.o., Prague

Milan Kvapil s.r.o., Prague

RS centrum - Neurologická klinika 1.LF UK a VFN v Praze, Prague

Ordinace MediFem, s.r.o., Teplice

CHU Bordeaux, Hôpital Pellegrin, Bordeaux

CHR Orléans, Service Rhumatologie, Orléans

CHU Saint Etienne, Hôpital Nord, Saint-Etienne

CHU Purpan, Toulouse

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche, Milan

IRCCS Ospedale San Raffaele /Unità di Endocrinologia, Milan

Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione, Napoli

UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo, Palermo

AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci, Pisa

Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia, Roma

Institut za reumatologiju, Belgrade

Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju, Kragujevac

"Institut za lečenje i rehabilitaciju Niška Banja Niš, Klinika za reumatologiju", Niška Banja

Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma, Novi Sad

Specijalna bolnica za reumatske bolesti Novi Sad, Novi Sad

"Opšta bolnica Đorđe Joanović Zrenjanin, Odeljenje za reumatologiju", Zrenjanin

IN MEDIC s.r.o., Neurologická ambulancia, Bardejov

ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie, Komárno

ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie, Košice

Endomed, s.r.o. - Gastroenterologická ambulancia, Košice

DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie, Levice

KARDIO 1, s.r.o., Kardiologická ambulancia, Lučenec

Elte HU, s.r.o., Chirurgická ambulancia, Rimavská Sobota

Kardioamb, s.r.o., Kardiologická a interná ambulancia, Rimavská Sobota

MEDILEX, s.r.o., Ambulancia vnútorného lekárstva, Rimavská Sobota

Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie, Rimavská Sobota

Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia, Spišská Nová Ves

ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie, Topoľčany

KK Neuro, s.r.o., Neurologická ambulancia, Žilina

Clínica Sagrada Familia, Barcelona

EAP Sardenya, Barcelona

Hospital del Mar, Barcelona

Hospital Quirónsalud Barcelona, Barcelona

Hospital Universitario Quirónsalud Madrid, Pozuelo de Alarcón

Complejo Asistencial Universitario de Salamanca, Salamanca

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Rio Hortega, Valladolid

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Faes Farma, S.A.

INDUSTRY

NCT04735926 - Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency | Biotech Hunter | Biotech Hunter