search
Back to results

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

Primary Purpose

Vitamin D Deficiency, Vitamin D Insufficiency

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Calcifediol 75mcg
Calcifediol 100mcg
Calcifediol 125mcg
Placebo
Placebo
Sponsored by
Faes Farma, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D deficiency, Hypovitaminosis D, Vitamin D Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1A

Group 1B

Group 1C

Group 2A

Group 2B

Group 2C

Arm Description

Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)

Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)

Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 29, 2021
Last Updated
September 14, 2023
Sponsor
Faes Farma, S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT04735926
Brief Title
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Vitamin D Insufficiency
Keywords
Vitamin D deficiency, Hypovitaminosis D, Vitamin D Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
674 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1A
Arm Type
Placebo Comparator
Arm Description
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Arm Title
Group 1B
Arm Type
Experimental
Arm Description
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Arm Title
Group 1C
Arm Type
Experimental
Arm Description
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Arm Title
Group 2A
Arm Type
Placebo Comparator
Arm Description
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Arm Title
Group 2B
Arm Type
Experimental
Arm Description
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Arm Title
Group 2C
Arm Type
Experimental
Arm Description
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Intervention Type
Drug
Intervention Name(s)
Calcifediol 75mcg
Intervention Description
Soft gelatin capsule. Oral administration once per week
Intervention Type
Drug
Intervention Name(s)
Calcifediol 100mcg
Intervention Description
Soft gelatin capsule. Oral administration once per week
Intervention Type
Drug
Intervention Name(s)
Calcifediol 125mcg
Intervention Description
Soft gelatin capsule. Oral administration once per week.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Soft gelatin capsule. Oral administration once per week.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Soft gelatin capsule. Oral administration once per week.
Primary Outcome Measure Information:
Title
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.
Description
Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
MC-1-Sevlievo Ltd.
City
Sevlievo
Country
Bulgaria
Facility Name
Diagnostic & Consultative Center "Sveta Anna" EOOD
City
Sofia
Country
Bulgaria
Facility Name
Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology
City
Sofia
Country
Bulgaria
Facility Name
IV MHAT - Sofia
City
Sofia
Country
Bulgaria
Facility Name
Lora - Medical center Sofia
City
Sofia
Country
Bulgaria
Facility Name
Medical Centre Asklepion - Research in human medicine
City
Sofia
Country
Bulgaria
Facility Name
Medical Centre Salvebis
City
Sofia
Country
Bulgaria
Facility Name
Alergologie Němcová, s.r.o.
City
Brno
Country
Czechia
Facility Name
Poliklinika Choceň - Neurologická ambulance
City
Choceň
Country
Czechia
Facility Name
MUDr. Eva Richterová - HK, s.r.o.
City
Hradec Králové
Country
Czechia
Facility Name
MUDr. Tomáš Edelsberger
City
Krnov
Country
Czechia
Facility Name
G-CENTRUM Olomouc s.r.o.
City
Olomouc
Country
Czechia
Facility Name
Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze
City
Praha
Country
Czechia
Facility Name
MediCel, s.r.o.
City
Praha
Country
Czechia
Facility Name
Milan Kvapil s.r.o.
City
Praha
Country
Czechia
Facility Name
RS centrum - Neurologická klinika 1.LF UK a VFN v Praze
City
Praha
Country
Czechia
Facility Name
Centrum gynekologické rehabilitace s.r.o.
City
Písek
Country
Czechia
Facility Name
Ordinace MediFem, s.r.o.
City
Teplice
Country
Czechia
Facility Name
CHU Bordeaux, Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
CHR Orléans, Service Rhumatologie
City
Orléans
Country
France
Facility Name
CHU Saint Etienne, Hôpital Nord
City
Saint-Étienne
Country
France
Facility Name
CHU Purpan
City
Toulouse
Country
France
Facility Name
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche
City
Milano
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele /Unità di Endocrinologia
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione
City
Napoli
Country
Italy
Facility Name
UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo
City
Palermo
Country
Italy
Facility Name
AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
City
Pisa
Country
Italy
Facility Name
Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia
City
Roma
Country
Italy
Facility Name
Institut za reumatologiju
City
Belgrade
Country
Serbia
Facility Name
Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju
City
Kragujevac
Country
Serbia
Facility Name
Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju
City
Niška Banja
Country
Serbia
Facility Name
Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma
City
Novi Sad
Country
Serbia
Facility Name
Specijalna bolnica za reumatske bolesti Novi Sad
City
Novi Sad
Country
Serbia
Facility Name
Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju
City
Zrenjanin
Country
Serbia
Facility Name
IN MEDIC s.r.o., Neurologická ambulancia
City
Bardejov
Country
Slovakia
Facility Name
ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie
City
Komárno
Country
Slovakia
Facility Name
ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie
City
Košice
Country
Slovakia
Facility Name
Endomed, s.r.o. - Gastroenterologická ambulancia
City
Košice
Country
Slovakia
Facility Name
DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie
City
Levice
Country
Slovakia
Facility Name
KARDIO 1, s.r.o., Kardiologická ambulancia
City
Lučenec
Country
Slovakia
Facility Name
Elte HU, s.r.o., Chirurgická ambulancia
City
Rimavská Sobota
Country
Slovakia
Facility Name
Kardioamb, s.r.o., Kardiologická a interná ambulancia
City
Rimavská Sobota
Country
Slovakia
Facility Name
MEDILEX, s.r.o., Ambulancia vnútorného lekárstva
City
Rimavská Sobota
Country
Slovakia
Facility Name
Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie
City
Rimavská Sobota
Country
Slovakia
Facility Name
Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia
City
Spišská Nová Ves
Country
Slovakia
Facility Name
ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie
City
Topoľčany
Country
Slovakia
Facility Name
KK Neuro, s.r.o., Neurologická ambulancia
City
Žilina
Country
Slovakia
Facility Name
Clínica Sagrada Familia
City
Barcelona
Country
Spain
Facility Name
EAP Sardenya
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Quirónsalud Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Quirónsalud Madrid
City
Pozuelo De Alarcón
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs