Vitamin D Levels in Adolescent Idiopathic Scoliosis

Completed

• Conditions: Vitamin D Deficiency; Scoliosis Idiopathic; BMD

• Registration Number: NCT03820895
• Lead Sponsor: Security Forces Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-10-01
• Primary Completion: 2018-08-20
• Status Verified: 2019-01
• Study Completion: 2019-01-10
• Study First Submitted: 2019-01-26
• Study First Submitted QC: 2019-01-26
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measure vitamin D level in AIS patients	Baseline	Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA).

Secondary Outcome Measures

Name	Time	Method
calculate Cobb's angle in AIS patients	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	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	Baseline	measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).