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The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03582917
Acronym
ScoliVit
Enrollment
80
Registered
2018-07-11
Start date
2018-09-20
Completion date
2025-12-20
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence

Brief 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.

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.

Interventions

DRUGAlphacalcidol

Alphacalcidol 0,5mg tablet

Sponsors

University of Ioannina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
25(OH)D48 weeksMeasurement of the major metabolite of vitamin D
X - rays48 weeksCobb angle measurement
Dexa48 weeksBMD and Z - score measurement
BMD (weight in kilograms, height in meters)48 weeksweight and height will be combined to report BMI in kg/m\^2

Countries

Greece

Contacts

Primary ContactLazaros Tagkalidis
akissdoc@hotmail.com+30 6977252028
Backup ContactAvraam Ploumis, Ass. Professor
aploumis@uoi.gr6932080701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026