MedPath

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

Phase 2
Completed
Conditions
Vitamin D Deficiency
Vitamin D Insufficiency
Interventions
Drug: Calcifediol 100mcg
Other: Placebo
Drug: Calcifediol 75mcg
Drug: Calcifediol 125mcg
Registration Number
NCT04735926
Lead Sponsor
Faes Farma, S.A.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
674
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1CCalcifediol 100mcgSubjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1APlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1BCalcifediol 75mcgSubjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1BPlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 2APlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2BCalcifediol 100mcgSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 1CPlaceboSubjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 2BPlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2CCalcifediol 125mcgSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2CPlaceboSubjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Primary Outcome Measures
NameTimeMethod
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.16 weeks

Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (55)

KK Neuro, s.r.o., Neurologická ambulancia

🇸🇰

Žilina, Slovakia

Hospital Universitario Rio Hortega

🇪🇸

Valladolid, Spain

Hospital Quirónsalud Barcelona

🇪🇸

Barcelona, Spain

Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie

🇸🇰

Rimavská Sobota, Slovakia

ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie

🇸🇰

Topoľčany, Slovakia

Hospital Universitario Quirónsalud Madrid

🇪🇸

Pozuelo De Alarcón, Spain

Hospital Universitario Marqués de Valdecilla

🇪🇸

Santander, Spain

Clínica Sagrada Familia

🇪🇸

Barcelona, Spain

Hospital del Mar

🇪🇸

Barcelona, Spain

MEDILEX, s.r.o., Ambulancia vnútorného lekárstva

🇸🇰

Rimavská Sobota, Slovakia

Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia

🇸🇰

Spišská Nová Ves, Slovakia

Complejo Asistencial Universitario de Salamanca

🇪🇸

Salamanca, Spain

ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie

🇸🇰

Komárno, Slovakia

Endomed, s.r.o. - Gastroenterologická ambulancia

🇸🇰

Košice, Slovakia

CHR Orléans, Service Rhumatologie

🇫🇷

Orléans, France

Ordinace MediFem, s.r.o.

🇨🇿

Teplice, Czechia

CHU Purpan

🇫🇷

Toulouse, France

MC-1-Sevlievo Ltd.

🇧🇬

Sevlievo, Bulgaria

Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology

🇧🇬

Sofia, Bulgaria

Diagnostic & Consultative Center "Sveta Anna" EOOD

🇧🇬

Sofia, Bulgaria

IV MHAT - Sofia

🇧🇬

Sofia, Bulgaria

Medical Centre Asklepion - Research in human medicine

🇧🇬

Sofia, Bulgaria

Lora - Medical center Sofia

🇧🇬

Sofia, Bulgaria

MUDr. Eva Richterová - HK, s.r.o.

🇨🇿

Hradec Králové, Czechia

Alergologie Němcová, s.r.o.

🇨🇿

Brno, Czechia

Poliklinika Choceň - Neurologická ambulance

🇨🇿

Choceň, Czechia

MUDr. Tomáš Edelsberger

🇨🇿

Krnov, Czechia

Medical Centre Salvebis

🇧🇬

Sofia, Bulgaria

Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze

🇨🇿

Praha, Czechia

Milan Kvapil s.r.o.

🇨🇿

Praha, Czechia

MediCel, s.r.o.

🇨🇿

Praha, Czechia

Centrum gynekologické rehabilitace s.r.o.

🇨🇿

Písek, Czechia

RS centrum - Neurologická klinika 1.LF UK a VFN v Praze

🇨🇿

Praha, Czechia

CHU Bordeaux, Hôpital Pellegrin

🇫🇷

Bordeaux, France

CHU Saint Etienne, Hôpital Nord

🇫🇷

Saint-Étienne, France

IRCCS Ospedale San Raffaele /Unità di Endocrinologia

🇮🇹

Milano, Italy

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche

🇮🇹

Milano, Italy

AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

🇮🇹

Pisa, Italy

UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo

🇮🇹

Palermo, Italy

Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione

🇮🇹

Napoli, 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

IN MEDIC s.r.o., Neurologická ambulancia

🇸🇰

Bardejov, Slovakia

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

ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie

🇸🇰

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

EAP Sardenya

🇪🇸

Barcelona, Spain

G-CENTRUM Olomouc s.r.o.

🇨🇿

Olomouc, Czechia

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