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NCT06138249 Clinical Trial

Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels

Hypovitaminosis D Clinical Trial

— VITD  

Official title:
Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06138249
Other study ID # VITD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date June 30, 2024

Study information
Verified date July 2023
Source Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Contact Silvana De Giorgi, AP
Phone 3389821930
Email silvana.degiorgi@uniba.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Hypovitaminosis D (<20ng/mL) Exclusion Criteria: - Osteoporosis (T score <-2.5SD) - Renal or hepatic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D

Locations
Country Name City State
Italy University of Bari Bari

Sponsors (4)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Angela Notarnicola, Davide Bizzoca, Silvana De Giorgi

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary level of Vitamin D Blood dosage of Vitamin D Between recruitment and 1 month
Primary level of Vitamin D Blood dosage of vitamin D Between recruitment and 6 month
Secondary DEXA DEXA is a radiographic measurement of Bone Mass Between recruitment and 18 months
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