NCT03582917

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Ioannina · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scoliosis; Adolescence

Interventions

Type	Name	Description
DRUG	Alphacalcidol	Alphacalcidol 0,5mg tablet

Timeline

• Start date: 2018-09-20
• Primary completion: 2025-12-20
• Completion: 2025-12-20
• First posted: 2018-07-11
• Last updated: 2024-12-06

Locations

2 sites across 1 country: Greece