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

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.