Vitamin D DeficiencyNCT06643650
Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.
An observational study of Vitamin D Deficiency and Osteoporosis, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Osteoporosis, Bone Loss, Age-Related
- What is being tested?
- CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 11 Mar 2022to May 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years of age with a low energy fracture will be included in the study.
Who may be able to join
- Patients > 18 years old
- Patients with a low energy fracture
- Vitamin D levels < 30 ng/ml
- Patients with available medical history before and after initiation of study treatment
- Patients providing informed consent for this study
Who cannot join
- Pregnant or breastfeeding women
- Patients receiving different osteoporosis treatment
- Patients with known hypersensitivity to vitamin D
- Patients participating in another similar study at the same time with other drugs
- Patients with vitamin D contraindications according to the medical instructions for use
- Patients with a fracture due to a traffic accident
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
KAT General Hospital of Attika
Kifissia, Attica, 14561
Efstathios Chronopoulos, Professor, 6944837793 ext. 0030, stathi24@yahoo.gr
About this study
Official title: PHASE IV Observational Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.
Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Vitamin D and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture.
The goal of vitamin D supplementation is to bring the serum 25-(OH)-D concentration above 30 ng/ml.
Read more
Clinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. Pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition).
This is an observational cohort study that will record data on the use of vitamin D in daily practice in patients with low-energy fractures.
The aim of this study is to measure vitamin D levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.
- Being tested
- CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML
- Medical subject headings
- Vitamin D Deficiency, Osteoporosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5MLDietary supplement
Also called DELTIUS ORAL.SOL 25000 IU/2,5ML
Cholecalciferol 25000IU/week for 3 months in both groups. 2nd group continues with 25000IU/month for following 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose) | Not described Receives: Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML | |
| 2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol | Not described Receives: Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
Measurement of 25(OH)D vitamin
Measured: 1 month, 3 months, 6 months and 12 months
Evaluation of BMD of the patients after receiving vitamin D supplementation
Measurement of Bone Mineral Density
Measured: 12 months
Secondary outcomes (7)
PTH
Measurement of blood test of Parathyroid Hormone
Measured: 1 month, 3 months, 6 months and 12 months
TSH
Measurement of blood test of Thyroid-stimulating Hormone
Measured: 1 month, 3 months, 6 months and 12 months
Ca
Measurement of blood test of Calcium levels
Measured: 1 month, 3 months, 6 months and 12 months
P
Measurement of blood test of Phosphorus levels
Measured: 1 month, 3 months, 6 months and 12 months
ALP
Measurement of blood test of Alkaline phosphatase levels
Measured: 1 month, 3 months, 6 months and 12 months
Al
Measurement of blood test of Albumin levels
Measured: 1 month, 3 months, 6 months and 12 months
Mg
Measurement of blood test of Magnesium levels
Measured: 1 month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start11 Mar 2022
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EFSTATHIOS CHRONOPOULOS, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643650
- Sponsor's protocol ID
- 945/11-03-2022
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE IV Observational Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.
- ClinicalTrials.gov ID
- NCT06643650
- Acronym / sponsor ID
- 945/11-03-2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Vitamin D and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture.
The goal of vitamin D supplementation is to bring the serum 25-(OH)-D concentration above 30 ng/ml.
Clinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. Pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition).
This is an observational cohort study that will record data on the use of vitamin D in daily practice in patients with low-energy fractures.
The aim of this study is to measure vitamin D levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose) | – | Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML |
| 2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol | – | Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age with a low energy fracture will be included in the study.
Key inclusion criteria (5 listed)
- Patients > 18 years old
- Patients with a low energy fracture
- Vitamin D levels < 30 ng/ml
- Patients with available medical history before and after initiation of study treatment
- Patients providing informed consent for this study
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Patients receiving different osteoporosis treatment
- Patients with known hypersensitivity to vitamin D
- Patients participating in another similar study at the same time with other drugs
- Patients with vitamin D contraindications according to the medical instructions for use
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 |
|---|---|---|
| CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5MLAlso: DELTIUS ORAL.SOL 25000 IU/2,5MLCholecalciferol 25000IU/week for 3 months in both groups. 2nd group continues with 25000IU/month for following 3 months. | Dietary supplement | 1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose), 2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol |
Primary outcome
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
Time frame: 1 month, 3 months, 6 months and 12 months
Measurement of 25(OH)D vitamin
Evaluation of BMD of the patients after receiving vitamin D supplementation
Time frame: 12 months
Measurement of Bone Mineral Density
7 secondary outcomes
PTH
Time frame: 1 month, 3 months, 6 months and 12 months
TSH
Time frame: 1 month, 3 months, 6 months and 12 months
Ca
Time frame: 1 month, 3 months, 6 months and 12 months
P
Time frame: 1 month, 3 months, 6 months and 12 months
ALP
Time frame: 1 month, 3 months, 6 months and 12 months
Al
Time frame: 1 month, 3 months, 6 months and 12 months
Mg
Time frame: 1 month, 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Osteoporosis, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efstathios Chronopoulos, MD, MSc, PhD (6944837793 ext. 0030, stathi24@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation (time frame: 1 month, 3 months, 6 months and 12 months). 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?
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 16 Oct 2024.