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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04735926

Acronym

WORFEROL

Enrollment

674

Registered

2021-02-03

Start date

2020-12-23

Completion date

2023-04-25

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, Vitamin D Insufficiency

Keywords

Vitamin D deficiency, Hypovitaminosis D, Vitamin D Insufficiency

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.

Interventions

DRUGCalcifediol 75mcg

Soft gelatin capsule. Oral administration once per week

DRUGCalcifediol 100mcg

Soft gelatin capsule. Oral administration once per week

DRUGCalcifediol 125mcg

Soft gelatin capsule. Oral administration once per week.

OTHERPlacebo

Soft gelatin capsule. Oral administration once per week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Bulgaria, Czechia, France, Italy, Serbia, Slovakia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026