MedDataX Logo

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

NCT ID: NCT03582917

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2025-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Scoliosis; Adolescence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alphacalscidol

0,5mg tablet by mouth, one each day for one year

Group Type EXPERIMENTAL

Alphacalcidol

Intervention Type DRUG

Alphacalcidol 0,5mg tablet

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alphacalcidol

Alphacalcidol 0,5mg tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Idiopathic Adolescent Scoliosis
* Risser sign \<3-4

Exclusion Criteria

* Neuromuscular diseases
* metabolic disease
* Liver, lung, thyroid and parathyroid gland disorders.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Papanikolaou General Hospital

Asvestochóri, , Greece

Site Status RECRUITING

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lazaros Tagkalidis

Role: CONTACT

Phone: +30 6977252028

Email: [email protected]

Avraam Ploumis, Ass. Professor

Role: CONTACT

Phone: 6932080701

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lazaros TagKalidis, MD

Role: primary

Avraam Ploumis

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UIoannina

Identifier Type: -

Identifier Source: org_study_id