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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Vitamin D Deficiency, Vitamin D Insufficiency

Intervention / Treatment
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* Drug: Calcifediol 75mcg
* Drug: Calcifediol 100mcg
* Drug: Calcifediol 125mcg
* Other: Placebo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1A<br>Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) | Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|
| Experimental: Group 1B<br>Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) | Drug: Calcifediol 75mcg<br>* Soft gelatin capsule. Oral administration once per week<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|
| Experimental: Group 1C<br>Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL) | Drug: Calcifediol 100mcg<br>* Soft gelatin capsule. Oral administration once per week<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|
| Placebo Comparator: Group 2A<br>Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) | Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|
| Experimental: Group 2B<br>Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) | Drug: Calcifediol 100mcg<br>* Soft gelatin capsule. Oral administration once per week<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|
| Experimental: Group 2C<br>Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL) | Drug: Calcifediol 125mcg<br>* Soft gelatin capsule. Oral administration once per week.<br>Other: Placebo<br>* Soft gelatin capsule. Oral administration once per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypovitaminosis D, Vitamin D Insufficiency, Vitamin D deficiency