Status:
COMPLETED
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
Lead Sponsor:
Faes Farma, S.A.
Conditions:
Vitamin D Deficiency
Vitamin D Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
674 Patients enrolled
Trial Details
Trial ID
NCT04735926
Start Date
December 23 2020
End Date
April 25 2023
Last Update
September 15 2023
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
MC-1-Sevlievo Ltd.
Sevlievo, Bulgaria
2
Diagnostic & Consultative Center "Sveta Anna" EOOD
Sofia, Bulgaria
3
Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology
Sofia, Bulgaria
4
IV MHAT - Sofia
Sofia, Bulgaria