Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
VITD
Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
1 other identifier
interventional
90
1 country
1
Brief Summary
Patients with hypovitaminosis D are randomized into three arms of treatment: Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 25, 2025
July 1, 2025
2.5 years
July 21, 2023
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
level of Vitamin D
Blood dosage of Vitamin D
Between recruitment and 1 month
level of Vitamin D
Blood dosage of vitamin D
Between recruitment and 6 month
Secondary Outcomes (1)
DEXA
Between recruitment and 18 months
Study Arms (3)
Calcifediol each month
EXPERIMENTALCalcifediol 0,266 mg each month
Cholecalciferol 25.000 UI
EXPERIMENTALCholecalciferol 25000UI each 15 days
Calcifediol 4 drops each day
EXPERIMENTALCalcifediol 4 drops each day
Interventions
Vitamin D
Eligibility Criteria
You may qualify if:
- Hypovitaminosis D (\<20ng/mL)
You may not qualify if:
- Osteoporosis (T score \<-2.5SD)
- Renal or hepatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Barilead
- Silvana De Giorgicollaborator
- Davide Bizzocacollaborator
- Angela Notarnicolacollaborator
Study Sites (1)
University of Bari
Bari, 70124, Italy
Related Publications (3)
Paterson C. Vitamin D deficiency: a diagnosis often missed. Br J Hosp Med (Lond). 2011 Aug;72(8):456-8, 460-2. doi: 10.12968/hmed.2011.72.8.456.
PMID: 21841591BACKGROUNDCastano L, Madariaga L, Grau G, Garcia-Castano A. 25(OH)Vitamin D Deficiency and Calcifediol Treatment in Pediatrics. Nutrients. 2022 Apr 29;14(9):1854. doi: 10.3390/nu14091854.
PMID: 35565821BACKGROUNDHaddow JE. Vitamin D and rickets: much has been accomplished, but there is room for improvement. J Med Screen. 2011;18(2):58-9. doi: 10.1258/jms.2011.011059. No abstract available.
PMID: 21852696BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Angela Notarnicola, AP
University of Bari
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2023
First Posted
November 18, 2023
Study Start
July 1, 2023
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 25, 2025
Record last verified: 2025-07