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

NCT04735926 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2023-09-15

No results posted yet for this study

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

Interventions

DRUG

Calcifediol 75mcg

Soft gelatin capsule. Oral administration once per week

DRUG

Calcifediol 100mcg

Soft gelatin capsule. Oral administration once per week

DRUG

Calcifediol 125mcg

Soft gelatin capsule. Oral administration once per week.

OTHER

Placebo

Soft gelatin capsule. Oral administration once per week.

OTHER

Placebo

Soft gelatin capsule. Oral administration once per week.

Sponsors & Collaborators

  • Faes Farma, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-07-21
Completion
2023-04-25

Countries

  • Bulgaria
  • Czechia
  • France
  • Italy
  • Serbia
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735926 on ClinicalTrials.gov