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NCT Number: NCT06138249

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

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

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Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bari

Bari, 70124, Italy

Location status: Recruiting

Location contact

Silvana De Giorgi, AP

CONTACT

[email protected]

3389821930

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypovitaminosis D (<20ng/mL)

Exclusion criteria

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

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D

Primary outcomes

  1. level of Vitamin D

    Time frame: Between recruitment and 1 month

    Blood dosage of Vitamin D

  2. level of Vitamin D

    Time frame: Between recruitment and 6 month

    Blood dosage of vitamin D

Secondary outcomes

  1. DEXA

    Time frame: Between recruitment and 18 months

    DEXA is a radiographic measurement of Bone Mass

Study contacts

Contact information is provided by the study sponsor or research team.

Silvana De Giorgi, AP

CONTACT

[email protected]

3389821930

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

  • Angela Notarnicola
  • Davide Bizzoca
  • Silvana De Giorgi

Registry information

Official study title

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

Acronym: VITD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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