The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alphacalcidol.
- Who it may be relevant to
- Registry conditions: Scoliosis; Adolescence. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Alphacalcidol
Alphacalcidol 0,5mg tablet
Primary outcome measures
- 25(OH)D [Time frame: 48 weeks]
- X - rays [Time frame: 48 weeks]
- Dexa [Time frame: 48 weeks]
- BMD (weight in kilograms, height in meters) [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- Idiopathic Adolescent Scoliosis
- Risser sign <3-4
Exclusion criteria
- Neuromuscular diseases
- metabolic disease
- Liver, lung, thyroid and parathyroid gland disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Greece · 2 centers
- Papanikolaou General Hospital — Asvestochóri
- Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina — Ioannina
Identifiers
NCT: NCT03582917 · UIoannina