Study to investigate the efficacy and safety of 3 different weekly dosages of calcifediol (versus placebo) in patients suffering from Vitamin D deficiency or insufficiency
- Conditions
- Vitamin D deficiency or insufficiencyMedDRA version: 21.1Level: LLTClassification code 10053828Term: Blood 1,25-dihydroxy vitamin D decreasedSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-001099-14-CZ
- Lead Sponsor
- FAES FARMA S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 795
1. Male or female subjects = 18 years of age.
2. Evidence of serum 25-OH-D levels < 20 ng/mL or = 10 ng/mL, for each cohort respectively.
3. Written informed consent given freely after the nature of the clinical trial and disclosure of data has been explained to the subject.
4. For females of childbearing potential only: willing to perform pregnancy tests, must agree to use highly effective methods of birth control throughout the study. Highly effective methods of birth control include: combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that partner is the sole sexual partner of the clinical trial participant and has documentation of azoospermia) or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment). The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270
1. Subjects receiving any treatment with calcifediol, vitamin D analogues, vitamin complexes or vitamin D supplements within the last week before screening or planned during the clinical trial (except clinical trial rescue medication).
2. Subjects taking drugs that could modify vitamin D levels, i.e. phenobarbital, phenytoin, primidone, digoxin, rifampin, thiazide diuretics (hydrochlorothiazide), some antibiotics (penicillin, neomycin and chloramphenicol), antiretrovirals (tenofovir, adefovir), long-term corticosteroids (defined as a dose of prednisolone = 5 mg per day (or equivalent) for more than 3 months), verapamil, paraffin, mineral oil laxatives, magnesium salts, actinomycin, and antifungic imidazoles, within the last week before screening or planned during the clinical trial. Subjects taking orlistat, cholestyramine or colestipol who do not respect an interval of at least 2 hours before IP intake.
3. Subjects with confirmed osteoporosis.
4. Subjects aged 40 years or older with associated risk factors for osteoporosis determined by the Fracture Risk Assessment Tool (FRAX) if the ten-year risk of major osteoporotic fracture is = 20% OR if the ten-year risk of hip fracture is = 3%.
In subjects younger than 40 years old risk factors for osteoporosis will be assessed according to local guidelines. Subjects can only be included if their risk is negligible and their overall evaluation is considered adequate in the investigator’s opinion.
Exception: In both cases subjects can be included if a dual-energy x-ray absorptiometry (DXA) scan performed within 12 months before V1 with normal age-appropriate bone mineral density results in the lumbar spine and total proximal femur is available.
5. Subjects taking calcium supplements within the last week before screening or planned during the clinical trial.
6. Uncorrected hypercalcaemia (calcium > 10.5 mg/dL), known hypercalciuria or nephrolithiasis.
7. Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by CKD-EPI < 30 mL/min/1.73m2
8. Subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypoparathyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism.
9. Any present or previous malignancy within the last 5 years prior to the screening visit.
10. Known contraindications or sensitivities to the use of the IP or any of its components.
11. Pregnant woman, breastfeeding woman or woman planning a pregnancy.
12. Subject has received an IP (including investigational vaccines) or used an invasive investigational medical device within 30 days (or five half-lives of that IP, whichever is longer) before the start of the screening or is currently enrolled in an investigational interventional study.
13. Any condition that, in the opinion of the investigator, may jeopardise the clinical trial conduct according to the protocol (for example, evidence of diseases, medications or laboratory abnormalities that could alter the conduct of the study).
14. Employees of the investigator or clinical trial site, with direct involvement in the proposed study or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator.
15. Person committed to an institution by virtue of an order issued either by judicial or other authorities.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess efficacy for each cohort in terms of percentage of subjects who achieve 25-OH-D levels = 30 ng/mL and/or = 20 ng/mL at 16 weeks of treatment. ;Secondary Objective: 1. To assess efficacy in terms of further parameters based on 25-OH-D levels at different time points, also by age and BMI subgroups, as well as by treatment cohorts<br>2. To assess safety by treatment cohort;Primary end point(s): Percentage of responders by cohort, defined as a subject who achieves 25-OH-D levels = 30 ng/mL and/or = 20 ng/mL at 16 weeks of treatment.;Timepoint(s) of evaluation of this end point: At 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method