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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03582917
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : November 22, 2018
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

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.

Condition or disease Intervention/treatment Phase
Scoliosis; Adolescence Drug: Alphacalcidol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Alphacalscidol
0,5mg tablet by mouth, one each day for one year
Drug: Alphacalcidol
Alphacalcidol 0,5mg tablet

No Intervention: No treatment

Primary Outcome Measures :
  1. 25(OH)D [ Time Frame: 48 weeks ]
    Measurement of the major metabolite of vitamin D

  2. X - rays [ Time Frame: 48 weeks ]
    Cobb angle measurement

  3. Dexa [ Time Frame: 48 weeks ]
    BMD and Z - score measurement

  4. BMD (weight in kilograms, height in meters) [ Time Frame: 48 weeks ]
    weight and height will be combined to report BMI in kg/m^2

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients will be boys aged 10 to 18 and girls 10 to 16
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Idiopathic Adolescent Scoliosis
  • Risser sign <3-4

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03582917

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Contact: Lazaros Tagkalidis +30 6977252028
Contact: Avraam Ploumis, Ass. Professor 6932080701

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Papanikolaou General Hospital Recruiting
Asvestochori, Greece
Contact: Lazaros TagKalidis, MD    +30 6977252028   
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina Recruiting
Ioannina, Greece, 45100
Contact: Avraam Ploumis    6932080701   
Sponsors and Collaborators
University of Ioannina

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Responsible Party: Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina Identifier: NCT03582917     History of Changes
Other Study ID Numbers: UIoannina
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances