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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Adolescence
• Intervention / Treatment: Drug: Alphacalcidol

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lazaros Tagkalidis; Phone Number: +30 6977252028; Email: akissdoc@hotmail.com
• Study Contact Backup: Name: Avraam Ploumis, Ass. Professor; Phone Number: 6932080701; Email: aploumis@uoi.gr

Study Locations

• Greece
  • Asvestochori, Greece
    • Recruiting
    • Papanikolaou General Hospital
    • Contact: Lazaros TagKalidis, MD; Phone Number: +30 6977252028; Email: akissdoc@hotmail.com
  • Ioannina, Greece, 45100
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
    • Contact: Avraam Ploumis; Phone Number: 6932080701; Email: aploumis@uoi.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Idiopathic Adolescent Scoliosis
• Risser sign <3-4

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment
Experimental: Alphacalscidol; 0,5mg tablet by mouth, one each day for one year	Drug: Alphacalcidol; Alphacalcidol 0,5mg tablet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Alfacalcidol; Hydroxycholecalciferols
• Other Study ID Numbers: UIoannina

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No