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

Study Timeline

• Study Start: 2020-12-23
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Primary Completion: 2022-07-21
• Study Completion: 2023-04-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1C	Calcifediol 100mcg	Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1A	Placebo	Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1B	Calcifediol 75mcg	Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 1B	Placebo	Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 2A	Placebo	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2B	Calcifediol 100mcg	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 1C	Placebo	Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Group 2B	Placebo	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2C	Calcifediol 125mcg	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Group 2C	Placebo	Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (55)

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

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