Scoliosis; AdolescencePhase 2ScoliVitNCT03582917
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
A Phase 2 study testing Alphacalcidol in people with Scoliosis; Adolescence, run by University of Ioannina at 2 sites in Greece.
Trial summary
The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Alphacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGreece
- Study dates
- 20 Sep 2018to 20 Dec 2025
- Phase
- Phase 2
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Idiopathic Adolescent Scoliosis
- Risser sign <3-4
Who cannot join
- Neuromuscular diseases
- metabolic disease
- Liver, lung, thyroid and parathyroid gland disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Papanikolaou General Hospital
Asvestochóri
Lazaros TagKalidis, MD, +30 6977252028, akissdoc@hotmail.com
- Recruiting
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Ioannina, 45100
Avraam Ploumis, 6932080701, aploumis@uoi.gr
About this study
The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.
Read the detailed description
The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m ^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).
Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Alphacalcidol
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphacalcidolDrug
Alphacalcidol 0,5mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Alphacalscidol | Experimental | 0,5mg tablet by mouth, one each day for one year Receives: Drug: Alphacalcidol |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D
Measurement of the major metabolite of vitamin D
Measured: 48 weeks
X - rays
Cobb angle measurement
Measured: 48 weeks
Dexa
BMD and Z - score measurement
Measured: 48 weeks
BMD (weight in kilograms, height in meters)
weight and height will be combined to report BMI in kg/m^2
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start20 Sep 2018
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582917
- Sponsor's protocol ID
- UIoannina
- Acronym
- ScoliVit
- Status last verified
- Dec 2024
- First submitted
- 29 May 2018
- Last updated
- 6 Dec 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
- ClinicalTrials.gov ID
- NCT03582917
- Acronym / sponsor ID
- ScoliVit / UIoannina
- Conditions
- Scoliosis; Adolescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 11 Jul 2018 (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.
The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.
Detailed description
The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m ^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).
Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alphacalscidol | Experimental | Drug: Alphacalcidol0,5mg tablet by mouth, one each day for one year |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Idiopathic Adolescent Scoliosis
- Risser sign <3-4
Key exclusion criteria (3 listed)
- Neuromuscular diseases
- metabolic disease
- Liver, lung, thyroid and parathyroid gland disorders.
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 |
|---|---|---|
| AlphacalcidolAlphacalcidol 0,5mg tablet | Drug | Alphacalscidol |
Primary outcome
25(OH)D
Time frame: 48 weeks
Measurement of the major metabolite of vitamin D
X - rays
Time frame: 48 weeks
Cobb angle measurement
Dexa
Time frame: 48 weeks
BMD and Z - score measurement
BMD (weight in kilograms, height in meters)
Time frame: 48 weeks
weight and height will be combined to report BMI in kg/m^2
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 6 Dec 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alphacalcidol in people with Scoliosis; Adolescence, run by University of Ioannina at 2 sites 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 2 inclusion and 3 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lazaros Tagkalidis (+30 6977252028, akissdoc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25(OH)D (time frame: 48 weeks). The study lists 4 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 6 Dec 2024.