Vitamin D Levels in Adolescent Idiopathic Scoliosis

NCT03820895 | Completed DMC

• 1 other identifier: vit d in AIS
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scoliosis Idiopathic; Vitamin D Deficiency; BMD

Keywords

vitamin D; Cobb angle; alkaline phosphatase

Outcome Measures

Primary Outcomes (1)

• measure vitamin D level in AIS patients

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

  Baseline

Secondary Outcomes (3)

• calculate Cobb's angle in AIS patients

  Baseline

• measure BMD values in AIS patients

  Baseline

• measure Serum alkaline phosphatase (ALK) in AIS patients

  Baseline

Interventions

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.

Also known as: X-ray

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient who suffer from AIS and are eligible for corrective surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Security Forces Hospital: lead
• King Saud University: collaborator

Related Publications (9)

• Nowak R, Szota J, Mazurek U. Vitamin D receptor gene (VDR) transcripts in bone, cartilage, muscles and blood and microarray analysis of vitamin D responsive genes expression in paravertebral muscles of juvenile and adolescent idiopathic scoliosis patients. BMC Musculoskelet Disord. 2012 Dec 23;13:259. doi: 10.1186/1471-2474-13-259.

  PMID: 23259508 BACKGROUND

• Gozdzialska A, Jaskiewicz J, Knapik-Czajka M, Drag J, Gawlik M, Ciesla M, Kulis A, Zarzycki D, Lipik E. Association of Calcium and Phosphate Balance, Vitamin D, PTH, and Calcitonin in Patients With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Apr;41(8):693-7. doi: 10.1097/BRS.0000000000001286.

  PMID: 27064335 RESULT

• Konieczny MR, Senyurt H, Krauspe R. Epidemiology of adolescent idiopathic scoliosis. J Child Orthop. 2013 Feb;7(1):3-9. doi: 10.1007/s11832-012-0457-4. Epub 2012 Dec 11.

  PMID: 24432052 RESULT

• Al-Arjani AM, Al-Sebai MW, Al-Khawashki HM, Saadeddin MF. Epidemiological patterns of scoliosis in a spinal center in Saudi Arabia. Saudi Med J. 2000 Jun;21(6):554-7.

  PMID: 11500705 RESULT

• Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.

  PMID: 25269032 RESULT

• Adobor RD, Joranger P, Steen H, Navrud S, Brox JI. A health economic evaluation of screening and treatment in patients with adolescent idiopathic scoliosis. Scoliosis. 2014 Dec 6;9(1):21. doi: 10.1186/s13013-014-0021-8. eCollection 2014.

  PMID: 25601889 RESULT

• Lee WT, Cheung CS, Tse YK, Guo X, Qin L, Lam TP, Ng BK, Cheng JC. Association of osteopenia with curve severity in adolescent idiopathic scoliosis: a study of 919 girls. Osteoporos Int. 2005 Dec;16(12):1924-32. doi: 10.1007/s00198-005-1964-7. Epub 2005 Sep 15.

  PMID: 16163440 RESULT

• Al-Othman A, Al-Musharaf S, Al-Daghri NM, Krishnaswamy S, Yusuf DS, Alkharfy KM, Al-Saleh Y, Al-Attas OS, Alokail MS, Moharram O, Sabico S, Chrousos GP. Effect of physical activity and sun exposure on vitamin D status of Saudi children and adolescents. BMC Pediatr. 2012 Jul 3;12:92. doi: 10.1186/1471-2431-12-92.

  PMID: 22759399 RESULT

• Alsiddiky A, Alfadhil R, Al-Aqel M, Ababtain N, Almajed N, Bakarman K, Awwad W, Alatassi R. Assessment of serum vitamin D levels in surgical adolescent idiopathic scoliosis patients. BMC Pediatr. 2020 May 11;20(1):202. doi: 10.1186/s12887-020-02114-9.

  PMID: 32393207 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Hematologic Tests; X-Rays

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: January 29, 2019
• Study Start: October 1, 2016
• Primary Completion: August 20, 2018
• Study Completion: January 10, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01