Vitamin D Levels in Adolescent Idiopathic Scoliosis
|ClinicalTrials.gov Identifier: NCT03820895|
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment|
|Scoliosis Idiopathic Vitamin D Deficiency BMD||Diagnostic Test: Blood test|
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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Assessment of Serum Vitamin D Levels in Surgical Adolescent Idiopathic Scoliosis Patients|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||January 10, 2019|
- Diagnostic Test: Blood 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 Name: X-ray
- 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).
- 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.
- 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)
- measure Serum alkaline phosphatase (ALK) in AIS patients [ Time Frame: Baseline ]measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).