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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
674

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Clinica 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 Rio 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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