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NCT Number: NCT03582917

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

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.

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Key information

Conditions

Scoliosis; Adolescence Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Papanikolaou General Hospital, Asvestochóri, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic Adolescent Scoliosis
  • Risser sign <3-4

Exclusion criteria

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

Treatment and study plan

Alphacalcidol

Drug

Alphacalcidol 0,5mg tablet

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Avraam Ploumis, Ass. Professor

CONTACT

[email protected]

6932080701

Lazaros Tagkalidis

CONTACT

[email protected]

+30 6977252028

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Acronym: ScoliVit

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2018
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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