VITD: Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)
Overall Status
Recruiting
CT.gov ID
NCT06138249
Collaborator
Silvana De Giorgi (Other), Davide Bizzoca (Other), Angela Notarnicola (Other)
90
1
3
12
7.5
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 to support the best dosage of Vitamin D intake.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
Actual Study Start Date
:
Jul 1, 2023
Anticipated Primary Completion Date
:
Dec 30, 2023
Anticipated Study Completion Date
:
Jun 30, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Calcifediol each month Calcifediol 0,266 mg each month |
Dietary Supplement: Vitamin D
Vitamin D
|
| Experimental: Cholecalciferol 25.000 UI Cholecalciferol 25000UI each 15 days |
Dietary Supplement: Vitamin D
Vitamin D
|
| Experimental: Calcifediol 4 drops each day Calcifediol 4 drops each day |
Dietary Supplement: Vitamin D
Vitamin D
|
Outcome Measures
Primary Outcome Measures
- level of Vitamin D [Between recruitment and 1 month]
Blood dosage of Vitamin D
- level of Vitamin D [Between recruitment and 6 month]
Blood dosage of vitamin D
Secondary Outcome Measures
- DEXA [Between recruitment and 18 months]
DEXA is a radiographic measurement of Bone Mass
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hypovitaminosis D (<20ng/mL)
Exclusion Criteria:
-
Osteoporosis (T score <-2.5SD)
-
Renal or hepatic diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Bari | Bari | Italy | 70124 |
Sponsors and Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Silvana De Giorgi
- Davide Bizzoca
- Angela Notarnicola
Investigators
- Study Chair: Angela Notarnicola, AP, University of Bari
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Castano 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.
- Haddow 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.
- 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.
Responsible Party:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
ClinicalTrials.gov Identifier:
NCT06138249
Other Study ID Numbers:
- VITD
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: