The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

Scoliosis; Adolescence Clinical Trial

— ScoliVit  

Official title:

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03582917
• Other study ID #: UIoannina
• Status: Recruiting
• Phase: Phase 2
• Start date: September 20, 2018
• Est. completion date: September 20, 2025

Study information

• Verified date: March 2023
• Source: University of Ioannina
• Contact: Lazaros Tagkalidis
• Phone: +30 6977252028
• Email: akissdoc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Idiopathic Adolescent Scoliosis

• Risser sign <3-4

Exclusion Criteria:

• Neuromuscular diseases

• metabolic disease

• Liver, lung, thyroid and parathyroid gland disorders.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence

Intervention

Drug:
• Alphacalcidol
Alphacalcidol 0,5mg tablet

Locations

Country	Name	City	State
Greece	Papanikolaou General Hospital	Asvestochori
Greece	Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D	Measurement of the major metabolite of vitamin D	48 weeks
Primary	X - rays	Cobb angle measurement	48 weeks
Primary	Dexa	BMD and Z - score measurement	48 weeks
Primary	BMD (weight in kilograms, height in meters)	weight and height will be combined to report BMI in kg/m^2	48 weeks