Vitamin D Levels in Adolescent Idiopathic Scoliosis

Sponsor
Security Forces Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03820895
Collaborator
King Saud University (Other)
60
27.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood test

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Assessment of Serum Vitamin D Levels in Surgical Adolescent Idiopathic Scoliosis Patients
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Aug 20, 2018
Actual Study Completion Date :
Jan 10, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 25 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Security Forces Hospital
  • King Saud University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Raheef Alatassi, Orthopedic Surgeon, Security Forces Hospital
ClinicalTrials.gov Identifier:
NCT03820895
Other Study ID Numbers:
  • vit d in AIS
First Posted:
Jan 29, 2019
Last Update Posted:
Jan 30, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raheef Alatassi, Orthopedic Surgeon, Security Forces Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2019