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

November 20, 2025 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hypovitaminosis D (<20ng/mL)

Exclusion Criteria:

  • Osteoporosis (T score <-2.5SD)
  • Renal or hepatic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Dietary supplement: Vitamin D
Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of Vitamin D
Time Frame: Between recruitment and 1 month
Blood dosage of Vitamin D
Between recruitment and 1 month
level of Vitamin D
Time Frame: Between recruitment and 6 month
Blood dosage of vitamin D
Between recruitment and 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEXA
Time Frame: Between recruitment and 18 months
DEXA is a radiographic measurement of Bone Mass
Between recruitment and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborators

Silvana De Giorgi
Davide Bizzoca
Angela Notarnicola

Investigators

  • Study Chair: Angela Notarnicola, AP, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD (UAEU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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