NCT04735926

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

Randomised, Double-blind, Double-dummy, Multicentre Trial to Evaluate the Efficacy and Safety of Three Different Weekly Dosages of Calcifediol Versus Placebo in Subjects With Either Vitamin D Deficiency or Insufficiency.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 674 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-23
• Primary completion: 2022-07-21
• Completion: 2023-04-25
• First posted: 2021-02-03
• Last updated: 2023-09-15

Locations

55 sites across 7 countries: Bulgaria, Czechia, France, Italy, Serbia, Slovakia, Spain