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

September 14, 2023 updated by: Faes Farma, S.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

674

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sevlievo, Bulgaria
        • MC-1-Sevlievo Ltd.
      • Sofia, 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
  • Czechia
      • Brno, Czechia
        • Alergologie Němcová, s.r.o.
      • Choceň, Czechia
        • Poliklinika Choceň - Neurologická ambulance
      • Hradec Králové, Czechia
        • MUDr. Eva Richterová - HK, s.r.o.
      • Krnov, Czechia
        • MUDr. Tomas Edelsberger
      • Olomouc, Czechia
        • G-CENTRUM Olomouc s.r.o.
      • Praha, Czechia
        • Centrum pro diagnostiku a léčbu 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
      • Písek, Czechia
        • Centrum gynekologické rehabilitace s.r.o.
      • Teplice, Czechia
        • Ordinace MediFem, s.r.o.
  • France
      • Bordeaux, France
        • CHU Bordeaux, Hôpital Pellegrin
      • Orléans, France
        • CHR Orléans, Service Rhumatologie
      • Saint-Étienne, France
        • CHU Saint Etienne, Hôpital Nord
      • Toulouse, France
        • CHU Purpan
  • Italy
      • Milano, Italy
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche
      • Milano, Italy
        • IRCCS Ospedale San Raffaele /Unità di Endocrinologia
      • Napoli, Italy
        • Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione
      • Palermo, Italy
        • UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo
      • Pisa, Italy
        • AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
      • Roma, Italy
        • Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia
  • Serbia
      • Belgrade, Serbia
        • Institut za Reumatologiju
      • Kragujevac, Serbia
        • Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju
      • Niška Banja, Serbia
        • Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju
      • Novi Sad, Serbia
        • Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma
      • Novi Sad, Serbia
        • Specijalna bolnica za reumatske bolesti Novi Sad
      • Zrenjanin, Serbia
        • Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju
  • Slovakia
      • Bardejov, Slovakia
        • IN MEDIC s.r.o., Neurologická ambulancia
      • Komárno, Slovakia
        • ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie
      • Košice, Slovakia
        • ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie
      • Košice, Slovakia
        • Endomed, s.r.o. - Gastroenterologická ambulancia
      • Levice, Slovakia
        • DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie
      • Lučenec, Slovakia
        • KARDIO 1, s.r.o., Kardiologicka ambulancia
      • Rimavská Sobota, 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
      • Spišská Nová Ves, Slovakia
        • Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia
      • Topoľčany, Slovakia
        • ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie
      • Žilina, Slovakia
        • KK Neuro, s.r.o., Neurologická ambulancia
  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Clínica Sagrada Familia
      • Barcelona, Spain
        • EAP Sardenya
      • Barcelona, Spain
        • Hospital Quironsalud Barcelona
      • Pozuelo De Alarcón, Spain
        • Hospital Universitario Quironsalud Madrid
      • Salamanca, Spain
        • Complejo Asistencial Universitario de Salamanca
      • Santander, Spain
        • Hospital Universitario Marques de Valdecilla
      • Valladolid, Spain
        • Hospital Universitario Río Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1A
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Experimental: Group 1B
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Drug: Calcifediol 75mcg
Soft gelatin capsule. Oral administration once per week
Experimental: Group 1C
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Drug: Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week
Placebo Comparator: Group 2A
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Experimental: Group 2B
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Drug: Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week
Experimental: Group 2C
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Other: Placebo
Soft gelatin capsule. Oral administration once per week.
Drug: Calcifediol 125mcg
Soft gelatin capsule. Oral administration once per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 16 weeks
Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIDR-0320/DR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe