The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis (ScoliVit)

University of Ioannina

Status and phase: Enrolling; Phase 2

Conditions: Scoliosis; Adolescence

Treatments: Drug: Alphacalcidol

Study type: Interventional

Funder types: Other

Identifiers

NCT03582917

UIoannina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Idiopathic Adolescent Scoliosis
• Risser sign <3-4

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Alphacalscidol

Experimental group

Description:

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

Treatment:

Drug: Alphacalcidol

No treatment

No Intervention group