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Recruiting NCT06138249

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

No phase Interventional Hypovitaminosis D

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D.
Who it may be relevant to
Registry conditions: Hypovitaminosis D. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Dietary supplement Vitamin D
    Vitamin D

Primary outcome measures

  • level of Vitamin D [Time frame: Between recruitment and 1 month]
  • level of Vitamin D [Time frame: Between recruitment and 6 month]
Secondary outcome measures (1)
  • DEXA [Time frame: Between recruitment and 18 months]

Eligibility criteria

Inclusion criteria

  • Hypovitaminosis D (<20ng/mL)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • University of Bari — Bari

Publications

  • 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. PMID 21841591
  • 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. PMID 35565821
  • 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. PMID 21852696

Identifiers

NCT: NCT06138249 · VITD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗