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Completed

NCT Number: NCT03820895

Vitamin D Levels in Adolescent Idiopathic Scoliosis

This study aims to estimate the prevalence of vitamin D insufficiency among patients with adolescent idiopathic scoliosis, to calculate the differences in serum vitamin D levels, Cobb angles, spinal bone mass densities, and serum alkaline phosphatase levels between genders in the sample, and to assess the possibility of a correlation between any of these factors in those surgical patients.

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

About this study

Adolescent Idiopathic Scoliosis (AIS) is a major public health problem and despite its relative rareness, it reduces the quality of life. It is three-dimensional deformity where there is a lateral curving of the spine. The prevalence rate is 0.47-5.2%. The degree of the spinal curvature is evaluated by the Cobb angle. A Cobb angle of more than 10-15° is considered pathological. AIS occurs mostly in adolescents between 10 and 25 years of age, and is more prevalent among females.

Scoliosis is considered severe and requires surgical intervention when the Cobb angle exceeds 40o.

The etiology of AIS is still unknown. Genetic and non-genetic factors have been attributed to cause AIS. Among non-genetic factors is bone mineral density (BMD), as bone quality plays an important role in the derangement of bony mechanical stability. The prevalence of AIS with osteoporosis is approximately 20-38%. Osteoporosis is known to lower the bone strength.

Vitamin D plays an essential role in maintaining a healthy mineralized skeleton. It helps with calcium absorption, and patients with a deficiency of Vitamin D can have difficulties in producing new bone and maintaining their bone strength.

In this study, the prevalence of vitamin D insufficiency among patients with AIS was evaluated. Gender differences in serum vitamin D levels, Cobb angles, BMD, and serum alkaline phosphatase levels were measured. Further correlation of Vitamin D with Cobb angles, BMD, and serum ALP levels was also evaluated.

Who can participate

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

Inclusion criteria

  • AIS patients of either gender
  • Aged between 10-25 years old
  • Had Cobb angles of 40o or more (i.e. requiring corrective surgery)
  • Had their serum vitamin D levels measured prior to their corrective surgery.

Exclusion criteria

  • Patients with non-idiopathic scoliosis (such as congenital or neuromuscular condition)
  • Younger than 10 years
  • Older than 25 years of age
  • Who did not have their serum vitamin D levels present on the system.

Treatment and study plan

Blood test

Diagnostic Test

Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA). Cobb's angle measurement was done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.

Other names: X-ray

Primary outcomes

  1. measure vitamin D level in AIS patients

    Time frame: Baseline

    Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA).

Secondary outcomes

  1. calculate Cobb's angle in AIS patients

    Time frame: Baseline

    done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.

  2. measure BMD values in AIS patients

    Time frame: Baseline

    were taken from the spine only by the use of a dual energy x-ray absorptiometry (DXA) scanner (Lunar, General Electric (GE) medical systems, UK)

  3. measure Serum alkaline phosphatase (ALK) in AIS patients

    Time frame: Baseline

    measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).

Sponsors and collaborators

Lead sponsor

Security Forces Hospital

Other

Collaborators

  • King Saud University

Registry information

Official study title

Assessment of Serum Vitamin D Levels in Surgical Adolescent Idiopathic Scoliosis Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Jan 30, 2019

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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