Hypovitaminosis DVITDNCT06138249
Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
A study testing Vitamin D in people with Hypovitaminosis D, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypovitaminosis D (<20ng/mL)
Who cannot join
- Osteoporosis (T score <-2.5SD)
- Renal or hepatic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Bari
Bari, 70124
Silvana De Giorgi, AP, 3389821930, silvana.degiorgi@uniba.it
About this study
Official title: 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
Read the 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.
- Conditions
- Hypovitaminosis D
- Being tested
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Calcifediol each month | Experimental | Calcifediol 0,266 mg each month Receives: Dietary Supplement: Vitamin D |
| Cholecalciferol 25.000 UI | Experimental | Cholecalciferol 25000UI each 15 days Receives: Dietary Supplement: Vitamin D |
| Calcifediol 4 drops each day | Experimental | Calcifediol 4 drops each day Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of Vitamin D
Blood dosage of Vitamin D
Measured: Between recruitment and 1 month
level of Vitamin D
Blood dosage of vitamin D
Measured: Between recruitment and 6 month
Secondary outcomes (1)
DEXA
DEXA is a radiographic measurement of Bone Mass
Measured: Between recruitment and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Silvana De Giorgi, Davide Bizzoca, Angela Notarnicola
- Responsible party
- Sponsor
- Investigators
- Angela Notarnicola, AP, Study chair, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138249
- Sponsor's protocol ID
- VITD
- Acronym
- VITD
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21841591Castano 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.
PubMed 35565821Haddow 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.
PubMed 21852696
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06138249
- Acronym / sponsor ID
- VITD / VITD
- Conditions
- Hypovitaminosis D
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Silvana De Giorgi, Davide Bizzoca, Angela Notarnicola
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcifediol each month | Experimental | Dietary Supplement: Vitamin DCalcifediol 0,266 mg each month |
| Cholecalciferol 25.000 UI | Experimental | Dietary Supplement: Vitamin DCholecalciferol 25000UI each 15 days |
| Calcifediol 4 drops each day | Experimental | Dietary Supplement: Vitamin DCalcifediol 4 drops each day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypovitaminosis D (<20ng/mL)
Key exclusion criteria (2 listed)
- Osteoporosis (T score <-2.5SD)
- Renal or hepatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D | Dietary supplement | Calcifediol 4 drops each day, Calcifediol each month, Cholecalciferol 25.000 UI |
Primary outcome
level of Vitamin D
Time frame: Between recruitment and 1 month
Blood dosage of Vitamin D
level of Vitamin D
Time frame: Between recruitment and 6 month
Blood dosage of vitamin D
1 secondary outcome
DEXA
Time frame: Between recruitment and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 21841591Paterson 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.
- Background: PubMed 35565821Castano 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.
- Background: PubMed 21852696Haddow 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.
- pubmedLink provided by the sponsor.
Related trials for Hypovitaminosis D
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Notarnicola, AP study chair
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Hypovitaminosis D, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvana De Giorgi, AP (3389821930, silvana.degiorgi@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of Vitamin D (time frame: Between recruitment and 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138249, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.