Vitamin D DeficiencyPhase 2/3WORFEROLNCT04735926

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

A Phase 2/3 study testing Calcifediol 75mcg, Calcifediol 100mcg and Calcifediol 125mcg in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by Faes Farma, S.A. at 55 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitamin D Deficiency, Vitamin D Insufficiency
What is being tested?: Calcifediol 75mcg, Calcifediol 100mcg and Calcifediol 125mcg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 674 participants
Where: 55 sitesin 7 countries
Study dates: 23 Dec 2020to 25 Apr 2023
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

55 sites in 7 countries.

Country

City, postcode or hospital

55 sites in 7 countries

Slovakia13 sites

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

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Czechia11 sites

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

Other trials in Czechia

Spain8 sites

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

Other trials in Spain

Bulgaria7 sites

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

Other trials in Bulgaria

Italy6 sites

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
Naples
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

Other trials in Italy

Serbia6 sites

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

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France4 sites

CHU Bordeaux, Hôpital Pellegrin
Bordeaux
CHR Orléans, Service Rhumatologie
Orléans
CHU Saint Etienne, Hôpital Nord
Saint-Etienne
CHU Purpan
Toulouse

Other trials in France

About this study

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.

Conditions: Vitamin D Deficiency, Vitamin D Insufficiency
Being tested: Calcifediol 75mcg, Calcifediol 100mcg, Calcifediol 125mcg, Placebo
Keywords: Vitamin D deficiency, Hypovitaminosis D, Vitamin D Insufficiency
Medical subject headings: Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcifediol 75mcgDrug
Soft gelatin capsule. Oral administration once per week
Calcifediol 100mcgDrug
Soft gelatin capsule. Oral administration once per week
Calcifediol 125mcgDrug
Soft gelatin capsule. Oral administration once per week.
PlaceboOther
Soft gelatin capsule. Oral administration once per week.
PlaceboOther
Soft gelatin capsule. Oral administration once per week.

Study groups in NCT04735926
Study group	Role	What they receive
Group 1A	Placebo comparator	Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) Receives: Other: Placebo
Group 1B	Experimental	Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) Receives: Drug: Calcifediol 75mcg; Other: Placebo
Group 1C	Experimental	Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) Receives: Drug: Calcifediol 100mcg; Other: Placebo
Group 2A	Placebo comparator	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) Receives: Other: Placebo
Group 2B	Experimental	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) Receives: Drug: Calcifediol 100mcg; Other: Placebo
Group 2C	Experimental	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) Receives: Drug: Calcifediol 125mcg; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 202025 Apr 2023

First posted3 Feb 2021
Study start23 Dec 2020
Primary completion21 Jul 2022
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 674 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04735926
Sponsor's protocol ID: HIDR-0320/DR
Acronym: WORFEROL
Status last verified: Sep 2023
First submitted: 29 Jan 2021
Last updated: 15 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04735926
Acronym / sponsor ID: WORFEROL / HIDR-0320/DR
Conditions: Vitamin D Deficiency, Vitamin D Insufficiency
Keywords: Vitamin D deficiency, Hypovitaminosis D, Vitamin D Insufficiency
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 674 participants (actual)
Lead sponsor: Faes Farma, S.A.Industry (pharma, biotech, devices)
Study start: 23 Dec 2020 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 3 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1A	Placebo comparator	Other: PlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Group 1B	Experimental	Drug: Calcifediol 75mcg, Other: PlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Group 1C	Experimental	Drug: Calcifediol 100mcg, Other: PlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
Group 2A	Placebo comparator	Other: PlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2B	Experimental	Drug: Calcifediol 100mcg, Other: PlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2C	Experimental	Drug: Calcifediol 125mcg, Other: PlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcifediol 75mcgSoft gelatin capsule. Oral administration once per week	Drug	Group 1B
Calcifediol 100mcgSoft gelatin capsule. Oral administration once per week	Drug	Group 1C, Group 2B
Calcifediol 125mcgSoft gelatin capsule. Oral administration once per week.	Drug	Group 2C
PlaceboSoft gelatin capsule. Oral administration once per week.	Other	Group 1A, Group 1B, Group 1C, Group 2A, Group 2B, Group 2C
PlaceboSoft gelatin capsule. Oral administration once per week.	Other	Group 1A, Group 2A

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Individual participant dataSharing planned: No

Related trials for Vitamin D Deficiency

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

55 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Slovakia, Czechia, Spain, Bulgaria, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04735926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.