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ScoliVit: The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

Sponsor
University of Ioannina (Other)
Overall Status
Recruiting
CT.gov ID
NCT03582917
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
48
Anticipated Duration (Months)
40
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 20, 2018
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 25(OH)D [48 weeks]

    Measurement of the major metabolite of vitamin D

  2. X - rays [48 weeks]

    Cobb angle measurement

  3. Dexa [48 weeks]

    BMD and Z - score measurement

  4. BMD (weight in kilograms, height in meters) [48 weeks]

    weight and height will be combined to report BMI in kg/m^2

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Papanikolaou General Hospital Asvestochori Greece
2 Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina Ioannina Greece 45100

Sponsors and Collaborators

  • University of Ioannina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina
ClinicalTrials.gov Identifier:
NCT03582917
Other Study ID Numbers:
  • UIoannina
First Posted:
Jul 11, 2018
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Scoliosis
Alfacalcidol
Hydroxycholecalciferols

Study Results

No Results Posted as of May 20, 2022