Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency (WORFEROL)
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| ClinicalTrials.gov Identifier: NCT04735926 |
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Recruitment Status :
Completed
First Posted : February 3, 2021
Last Update Posted : September 15, 2023
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Sponsor:
Faes Farma, S.A.
Information provided by (Responsible Party):
Faes Farma, S.A.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vitamin D Deficiency Vitamin D Insufficiency | Drug: Calcifediol 75mcg Drug: Calcifediol 100mcg Drug: Calcifediol 125mcg Other: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 674 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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. |
| Actual Study Start Date : | December 23, 2020 |
| Actual Primary Completion Date : | July 21, 2022 |
| Actual Study Completion Date : | April 25, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Group 1A
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
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Other: Placebo
Soft gelatin capsule. Oral administration once per week. Other: Placebo Soft gelatin capsule. Oral administration once per week. |
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Experimental: Group 1B
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
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Drug: Calcifediol 75mcg
Soft gelatin capsule. Oral administration once per week Other: Placebo Soft gelatin capsule. Oral administration once per week. |
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Experimental: Group 1C
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
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Drug: Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week Other: Placebo Soft gelatin capsule. Oral administration once per week. |
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Placebo Comparator: Group 2A
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
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Other: Placebo
Soft gelatin capsule. Oral administration once per week. Other: Placebo Soft gelatin capsule. Oral administration once per week. |
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Experimental: Group 2B
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
|
Drug: Calcifediol 100mcg
Soft gelatin capsule. Oral administration once per week Other: Placebo Soft gelatin capsule. Oral administration once per week. |
|
Experimental: Group 2C
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
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Drug: Calcifediol 125mcg
Soft gelatin capsule. Oral administration once per week. Other: Placebo Soft gelatin capsule. Oral administration once per week. |
Primary Outcome Measures :
- 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. [ Time Frame: 16 weeks ]Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735926
Locations
Show 55 study locations
Sponsors and Collaborators
Faes Farma, S.A.
| Responsible Party: | Faes Farma, S.A. |
| ClinicalTrials.gov Identifier: | NCT04735926 |
| Other Study ID Numbers: |
HIDR-0320/DR |
| First Posted: | February 3, 2021 Key Record Dates |
| Last Update Posted: | September 15, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Faes Farma, S.A.:
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Vitamin D deficiency Hypovitaminosis D Vitamin D Insufficiency |
Additional relevant MeSH terms:
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Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Calcifediol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |