- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582917
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis (ScoliVit)
Study Overview
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
Enrollment (Anticipated)
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
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
|
Alphacalcidol 0,5mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
25(OH)D
Time Frame: 48 weeks
|
Measurement of the major metabolite of vitamin D
|
48 weeks
|
X - rays
Time Frame: 48 weeks
|
Cobb angle measurement
|
48 weeks
|
Dexa
Time Frame: 48 weeks
|
BMD and Z - score measurement
|
48 weeks
|
BMD (weight in kilograms, height in meters)
Time Frame: 48 weeks
|
weight and height will be combined to report BMI in kg/m^2
|
48 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UIoannina
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scoliosis; Adolescence
-
University of HaifaRecruitingScoliosis Idiopathic | Scoliosis; AdolescenceIsrael
-
Istituto Scientifico Italiano Colonna VertebraleCompletedScoliosis Idiopathic | Scoliosis; AdolescenceItaly
-
Manhattan Physical Medicine and Rehabilitation,...RecruitingScoliosis Idiopathic | Scoliosis; Adolescence | Scoliosis; Lumbar RegionUnited States
-
Universitat Jaume IRecruitingScoliosis Idiopathic | Scoliosis; Adolescence | BraceSpain
-
Istanbul University - Cerrahpasa (IUC)Not yet recruiting
-
Mayo ClinicRecruiting
-
Mehmet Hanifi KayaKirsehir Ahi Evran UniversitesiCompleted
-
Changhua Christian HospitalRecruiting
-
Medicrea, USA Corp.WithdrawnScoliosis; Adolescence
-
Asan Medical CenterCompletedScoliosis; AdolescenceKorea, Republic of
Clinical Trials on Alphacalcidol
-
University of AthensCompletedHypoparathyroidism PostproceduralGreece