Vitamin D Levels in Adolescent Idiopathic Scoliosis

Vitamin D Deficiency Clinical Trial

Official title:

Assessment of Serum Vitamin D Levels in Surgical Adolescent Idiopathic Scoliosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820895
• Other study ID #: vit d in AIS
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Security Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2019
• Est. primary completion date: August 20, 2018
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• BMD
• Scoliosis
• Scoliosis Idiopathic
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Security Forces Hospital	King Saud University

References & Publications (8)

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. — View Citation

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. — View Citation

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. BM — View Citation

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). 2 — View Citation

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. Review. — View Citation

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. Epub 2005 Sep 15. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	calculate Cobb's angle in AIS patients	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.	Baseline
Secondary	measure BMD values in AIS patients	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)	Baseline
Secondary	measure Serum alkaline phosphatase (ALK) in AIS patients	measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).	Baseline