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

NCT04735926 | Completed Phase 2

• 1 other identifier: HIDR-0320/DR
• Study Type: interventional
• Target: 674
• Locations: 7 countries
• Sites: 55

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.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Keywords

Vitamin D deficiency; Hypovitaminosis D; Vitamin D Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Study Arms (6)

Group 1A

PLACEBO COMPARATOR

Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)

Other: Placebo

Group 1B

EXPERIMENTAL

Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)

Drug: Calcifediol 75mcg; Other: Placebo

Group 1C

EXPERIMENTAL

Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)

Drug: Calcifediol 100mcg; Other: Placebo

Group 2A

PLACEBO COMPARATOR

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Other: Placebo

Group 2B

EXPERIMENTAL

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Drug: Calcifediol 100mcg; Other: Placebo

Group 2C

EXPERIMENTAL

Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Drug: Calcifediol 125mcg; Other: Placebo

Interventions

Calcifediol 75mcg DRUG

Soft gelatin capsule. Oral administration once per week

Group 1B

Calcifediol 100mcg DRUG

Soft gelatin capsule. Oral administration once per week

Group 1C; Group 2B

Calcifediol 125mcg DRUG

Soft gelatin capsule. Oral administration once per week.

Group 2C

Placebo OTHER

Soft gelatin capsule. Oral administration once per week.

Group 1A; Group 1B; Group 1C; Group 2A; Group 2B; Group 2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faes Farma, S.A.: lead

Study Sites (55)

MC-1-Sevlievo Ltd.

Sevlievo, Bulgaria

Location

Diagnostic & Consultative Center "Sveta Anna" EOOD

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

IV MHAT - Sofia

Sofia, Bulgaria

Location

Lora - Medical center Sofia

Sofia, Bulgaria

Location

Medical Centre Asklepion - Research in human medicine

Sofia, Bulgaria

Location

Medical Centre Salvebis

Sofia, Bulgaria

Location

Alergologie Němcová, s.r.o.

Brno, Czechia

Location

Poliklinika Choceň - Neurologická ambulance

Choceň, Czechia

Location

MUDr. Eva Richterová - HK, s.r.o.

Hradec Králové, Czechia

Location

MUDr. Tomáš Edelsberger

Krnov, Czechia

Location

G-CENTRUM Olomouc s.r.o.

Olomouc, Czechia

Location

Centrum gynekologické rehabilitace s.r.o.

Písek, Czechia

Location

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

Prague, Czechia

Location

MediCel, s.r.o.

Prague, Czechia

Location

Milan Kvapil s.r.o.

Prague, Czechia

Location

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

Prague, Czechia

Location

Ordinace MediFem, s.r.o.

Teplice, Czechia

Location

CHU Bordeaux, Hôpital Pellegrin

Bordeaux, France

Location

CHR Orléans, Service Rhumatologie

Orléans, France

Location

CHU Saint Etienne, Hôpital Nord

Saint-Etienne, France

Location

CHU Purpan

Toulouse, France

Location

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

Milan, Italy

Location

IRCCS Ospedale San Raffaele /Unità di Endocrinologia

Milan, Italy

Location

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

Napoli, Italy

Location

UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo

Palermo, Italy

Location

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

Pisa, Italy

Location

Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia

Roma, Italy

Location

Institut za reumatologiju

Belgrade, Serbia

Location

Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju

Kragujevac, Serbia

Location

Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju

Niška Banja, Serbia

Location

Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma

Novi Sad, Serbia

Location

Specijalna bolnica za reumatske bolesti Novi Sad

Novi Sad, Serbia

Location

Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju

Zrenjanin, Serbia

Location

IN MEDIC s.r.o., Neurologická ambulancia

Bardejov, Slovakia

Location

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

Komárno, Slovakia

Location

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

Košice, Slovakia

Location

Endomed, s.r.o. - Gastroenterologická ambulancia

Košice, Slovakia

Location

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

Levice, Slovakia

Location

KARDIO 1, s.r.o., Kardiologická ambulancia

Lučenec, Slovakia

Location

Elte HU, s.r.o., Chirurgická ambulancia

Rimavská Sobota, Slovakia

Location

Kardioamb, s.r.o., Kardiologická a interná ambulancia

Rimavská Sobota, Slovakia

Location

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

Rimavská Sobota, Slovakia

Location

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

Rimavská Sobota, Slovakia

Location

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

Spišská Nová Ves, Slovakia

Location

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

Topoľčany, Slovakia

Location

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

Žilina, Slovakia

Location

Clínica Sagrada Familia

Barcelona, Spain

Location

EAP Sardenya

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Quirónsalud Barcelona

Barcelona, Spain

Location

Hospital Universitario Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, Spain

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: December 23, 2020
• Primary Completion: July 21, 2022
• Study Completion: April 25, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (7); ES (8); FR (4); IT (6); SE (6); SL (13); CZ (11)