Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
NCT ID: NCT04735926
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
674 participants
INTERVENTIONAL
2020-12-23
2023-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1A
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Placebo
Soft gelatin capsule. Oral administration once per week.
Placebo
Soft gelatin capsule. Oral administration once per week.
Group 1B
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Calcifediol 75mcg
Soft gelatin capsule. Oral administration once per week
Placebo
Soft gelatin capsule. Oral administration once per week.
Group 1C
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week
Placebo
Soft gelatin capsule. Oral administration once per week.
Group 2A
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Placebo
Soft gelatin capsule. Oral administration once per week.
Placebo
Soft gelatin capsule. Oral administration once per week.
Group 2B
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week
Placebo
Soft gelatin capsule. Oral administration once per week.
Group 2C
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Calcifediol 125mcg
Soft gelatin capsule. Oral administration once per week.
Placebo
Soft gelatin capsule. Oral administration once per week.
Interventions
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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.
Placebo
Soft gelatin capsule. Oral administration once per week.
Placebo
Soft gelatin capsule. Oral administration once per week.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Faes Farma, S.A.
INDUSTRY
Responsible Party
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Locations
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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, , Bulgaria
Alergologie Němcová, s.r.o.
Brno, , Czechia
Poliklinika Choceň - Neurologická ambulance
Choceň, , 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 léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze
Prague, , Czechia
MediCel, s.r.o.
Prague, , Czechia
Milan Kvapil s.r.o.
Prague, , Czechia
RS centrum - Neurologická klinika 1.LF UK a VFN v Praze
Prague, , Czechia
Ordinace MediFem, s.r.o.
Teplice, , Czechia
CHU Bordeaux, Hôpital Pellegrin
Bordeaux, , France
CHR Orléans, Service Rhumatologie
Orléans, , France
CHU Saint Etienne, Hôpital Nord
Saint-Etienne, , France
CHU Purpan
Toulouse, , France
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche
Milan, , Italy
IRCCS Ospedale San Raffaele /Unità di Endocrinologia
Milan, , 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, , Italy
Institut za reumatologiju
Belgrade, , Serbia
Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju
Kragujevac, , Serbia
Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju
Niška Banja, , Serbia
Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma
Novi Sad, , Serbia
Specijalna bolnica za reumatske bolesti Novi Sad
Novi Sad, , Serbia
Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju
Zrenjanin, , Serbia
IN MEDIC s.r.o., Neurologická ambulancia
Bardejov, , Slovakia
ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie
Komárno, , Slovakia
ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie
Košice, , Slovakia
Endomed, s.r.o. - Gastroenterologická ambulancia
Košice, , Slovakia
DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie
Levice, , Slovakia
KARDIO 1, s.r.o., Kardiologická ambulancia
Lučenec, , 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
Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia
Spišská Nová Ves, , Slovakia
ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie
Topoľčany, , Slovakia
KK Neuro, s.r.o., Neurologická ambulancia
Žilina, , Slovakia
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, , Spain
Countries
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Other Identifiers
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HIDR-0320/DR
Identifier Type: -
Identifier Source: org_study_id
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