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Vitamin D Levels in Adolescent Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820895
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
King Saud University
Information provided by (Responsible Party):
Raheef Alatassi, 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.

Condition or disease Intervention/treatment
Scoliosis Idiopathic Vitamin D Deficiency BMD 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.

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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 : October 1, 2016
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient who suffer from AIS and are eligible for corrective surgery.
Criteria

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.

Publications of Results:

Other Publications:
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Responsible Party: Raheef Alatassi, Orthopedic Surgeon, Security Forces Hospital
ClinicalTrials.gov Identifier: NCT03820895    
Other Study ID Numbers: vit d in AIS
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raheef Alatassi, Security Forces Hospital:
vitamin D
Cobb angle
alkaline phosphatase
Additional relevant MeSH terms:
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Scoliosis
Vitamin D Deficiency
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents