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

Vitamin D Deficiency Clinical Trial

— WORFEROL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735926
• Other study ID #: HIDR-0320/DR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 23, 2020
• Est. completion date: April 25, 2023

Study information

• Verified date: September 2023
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Vitamin D Deficiency
• Vitamin D Insufficiency

Intervention

Drug:
• Calcifediol 75mcg
Soft gelatin capsule. Oral administration once per week
• Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week
• Calcifediol 125mcg
Soft gelatin capsule. Oral administration once per week.

Other:
• Placebo
Soft gelatin capsule. Oral administration once per week.
• Placebo
Soft gelatin capsule. Oral administration once per week.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Faes Farma, S.A.

Countries where clinical trial is conducted

Bulgaria,  Czechia,  France,  Italy,  Serbia,  Slovakia,  Spain, 

Outcome

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