Vitamin D deficiency or insufficiency MedDRA version: 21.1 Level: LLT Classification code 10053828 Term: Blood 1,25-dihydroxy vitamin D decreased System Organ Class: 100000004848
Conditions
Sponsors
FAES FARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects = 18 years of age. 2. Evidence of serum 25-OH-D levels =65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: 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 taking calcium supplements within the last week before screening or planned during the clinical trial. 4. Uncorrected hypercalcaemia (calcium > 10.5 mg/dL), known hypercalciuria or nephrolithiasis. 5. Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by CKD-EPI < 30 mL/min/1.73m2 6. Subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypoparathyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism. 7. Any present or previous malignancy within the last 5 years prior to the screening visit. 8. Known contraindications or sensitivities to the use of the IP or any of its components. 9. Pregnant woman, breastfeeding woman or woman planning a pregnancy. 10. 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. 11. 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). 12. 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. 13. Person committed to an institution by virtue of an order issued either by judicial or other authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of subjects achieving 25-OH-D levels = 20 ng/mL at 4, 24, 32 and 52 weeks of treatment. 2. Percentage of subjects achieving 25-OH-D levels = 30 ng/mL at 4, 24, 32 and 52 weeks of treatment. 3. Mean change from baseline in 25-OH-D levels at 4, 16, 24, 32 and 52 weeks of treatment. 4. Time to achieve 25-OH-D levels = 30 ng/mL. 5. Time to achieve 25-OH-D levels = 20 ng/mL. 6. Percentage of subjects in need of rescue medication, i.e. with 25-OH-D level = 10 ng/mL at 16, 24 and 32 weeks of treatment.. 7. Percentage of responders regarding seasonal variations. 8. Correlation between parathyroid hormone (PTH) and 25-OH-D levels at 16, 24 and 32 weeks of treatment. 9. Mean change from baseline in bone and mineral metabolism parameters (total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase levels) at 4, 16, 24, 32 and 52 weeks, as well as frequencies for values out of range and in range. 10. Percentage of treatment-emergent adverse events (TEAEs). 11. Percentage of related TEAEs 12. Percentage of TEAEs by severity 13. Percentage of serious TEAEs (related/unrelated), including TEAEs resulting in death 14. Frequency of TEAEs leading to discontinuation of study drug. 15. Haematology, frequencies for values out of range and in range. 16. Biochemistry, frequencies for values out of range and in range. 17. Physical examination and vital signs, clinically significant changes from baseline at 16, 24 and 52 weeks. 18. Percentage of subjects withdrawn from the study due to safety concerns. 19. Percentage of subjects reaching 25-OH-levels above 50, 60 and 70 ng/mL.;Timepoint(s) of evaluation of this end point: 1. At 4, 24, 32 and 52 weeks of treatment. 2. At 4, 24, 32 and 52 weeks of treatment. 3. At 4, 16, 24, 32 and 52 weeks of treatment 4. + 5. At any time during the 52 weeks of treatment 6. + 8. At 16, 24 and 32 weeks of treatment 9. At 4, 16, 24, 32 and 52 weeks of treatment 7. no timepoint applicable 17. | — |
Countries
Bulgaria, Czech Republic, France, Italy, Romania, Serbia, Slovakia, Spain
Contacts
Public ContactR&D+i Department
FAES FARMA S.A.
Outcome results
None listed