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

Primary Purpose

Scoliosis; Adolescence

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Alphacalcidol
Sponsored by
University of Ioannina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis; Adolescence

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Idiopathic Adolescent Scoliosis
  • Risser sign <3-4

Exclusion Criteria:

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

Sites / Locations

  • Papanikolaou General HospitalRecruiting
  • Department of Physical Medicine and Rehabilitation, University Hospital of IoanninaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alphacalscidol

No treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2018
Last Updated
March 1, 2023
Sponsor
University of Ioannina
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1. Study Identification

Unique Protocol Identification Number
NCT03582917
Brief Title
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Acronym
ScoliVit
Official Title
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alphacalscidol
Arm Type
Experimental
Arm Description
0,5mg tablet by mouth, one each day for one year
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Alphacalcidol
Intervention Description
Alphacalcidol 0,5mg tablet
Primary Outcome Measure Information:
Title
25(OH)D
Description
Measurement of the major metabolite of vitamin D
Time Frame
48 weeks
Title
X - rays
Description
Cobb angle measurement
Time Frame
48 weeks
Title
Dexa
Description
BMD and Z - score measurement
Time Frame
48 weeks
Title
BMD (weight in kilograms, height in meters)
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
48 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients will be boys aged 10 to 18 and girls 10 to 16
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Idiopathic Adolescent Scoliosis Risser sign <3-4 Exclusion Criteria: Neuromuscular diseases metabolic disease Liver, lung, thyroid and parathyroid gland disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lazaros Tagkalidis
Phone
+30 6977252028
Email
akissdoc@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Avraam Ploumis, Ass. Professor
Phone
6932080701
Email
aploumis@uoi.gr
Facility Information:
Facility Name
Papanikolaou General Hospital
City
Asvestochori
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaros TagKalidis, MD
Phone
+30 6977252028
Email
akissdoc@hotmail.com
Facility Name
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avraam Ploumis
Phone
6932080701
Email
aploumis@uoi.gr

12. IPD Sharing Statement

Learn more about this trial

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

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