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

NCT ID: NCT06138249

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Calcifediol each month

Calcifediol 0,266 mg each month

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Cholecalciferol 25.000 UI

Cholecalciferol 25000UI each 15 days

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Calcifediol 4 drops each day

Calcifediol 4 drops each day

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Interventions

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Vitamin D

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Hypovitaminosis D (\<20ng/mL)

Exclusion Criteria

* Osteoporosis (T score \<-2.5SD)
* Renal or hepatic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Silvana De Giorgi

UNKNOWN

Sponsor Role collaborator

Davide Bizzoca

UNKNOWN

Sponsor Role collaborator

Angela Notarnicola

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Notarnicola, AP

Role: STUDY_CHAIR

University of Bari

Locations

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University of Bari

Bari, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Silvana De Giorgi, AP

Role: CONTACT

3389821930

Facility Contacts

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Silvana De Giorgi, AP

Role: primary

3389821930

References

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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.

Reference Type BACKGROUND
PMID: 21852696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21841591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35565821 (View on PubMed)

Related Links

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Other Identifiers

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VITD

Identifier Type: -

Identifier Source: org_study_id

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