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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    795
  • sponsor
    Faes Farma, S.A.
Updated on 12 March 2021

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.

Details
Condition Vitamin D Deficiency, Vitamin Deficiency, Vitamin D Insufficiency
Treatment Placebo, Calcifediol 75mcg, Calcifediol 100mcg, Calcifediol 125mcg
Clinical Study IdentifierNCT04735926
SponsorFaes Farma, S.A.
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

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
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