Actively Recruiting
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Led by University of Ioannina · Updated on 2024-12-06
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of vitamin D in the development and recovery of spinal deformities in adolescents with idiopathic scoliosis. This prospective study aims to better understand how vitamin D levels may impact scoliosis during adolescence, a time of significant skeletal growth. The study is conducted by the University of Ioannina and is classified as a Phase 2 interventional trial. Participants will be divided into two groups based on their vitamin D levels. Those with normal vitamin D will not receive treatment, while those with low vitamin D will be given a daily 0.5 mg tablet of Alphacalcidol for one year. The study duration includes two years of follow-up with clinical exams every six months and yearly clinical, laboratory, and radiological assessments, including x-rays and bone density measurements. During the study, researchers will collect detailed medical histories and measure body size, bone density using DEXA scans, and blood tests for various markers including vitamin D and related hormones. Follow-up visits will monitor changes in scoliosis and bone health. The main outcomes measured at 48 weeks include vitamin D levels, x-rays, DEXA scans, and body mass index, helping to assess the effect of vitamin D treatment on scoliosis rehabilitation.
CONDITIONS
Brief Title
The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Idiopathic Adolescent Scoliosis
- Risser sign less than 3 to 4
- Age between 10 and 18 years
You will not qualify if you...
- Neuromuscular diseases
- Metabolic disease
- Liver, lung, thyroid and parathyroid gland disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants with low vitamin D levels receive Alphacalcidol 0.5mg daily by mouth for one year, while participants with normal vitamin D levels do not receive treatment. All participants are monitored during this period.
1 baseline visit and clinical, laboratory, and radiological examinations approximately annually during treatment
Duration - Up to 2 years total from enrollment
Participants are followed for a total of two years with clinical examinations every six months and clinical, laboratory, and radiological examinations annually to assess rehabilitation progress.
Clinical examinations every 6 months and clinical, laboratory, and radiological examinations once per year
Trial Site Locations
Total: 2 locations
1
Papanikolaou General Hospital
Asvestochóri, Greece
Actively Recruiting
2
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Ioannina, Greece, 45100
Actively Recruiting
Research Team
L
Lazaros Tagkalidis
A
Avraam Ploumis, Ass. Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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