Association Of Serum Vitamin D Level With Isthmic Spondylolysis

Spondylolysis Clinical Trial

Official title:

A Prospective Study On Association Of Serum Vitamin D Level With Isthmic Spondylolysis In Adult Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06284967
• Other study ID #: Vitamin D In Spondylolysis
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Mina Emad Zakaria Nasif, R. Doctor
• Phone: 01220033831
• Email: me3049585[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group.

Description:

Deficiency of 25-hydroxy vitamin D has been of recent interest , and its high prevalence has been confirmed across all age groups in many cross sectional studies, particularly in developing countries and in the Middle East and Northern Africa Region . The formation and maintenance of a structurally stiff and resilient skeleton is dependent upon vitamin D's role in absorption of calcium from the gut and in normal bone metabolism thereafter. Failure of adequate mineral accretion reduces normal bone turnover and may result in rickets, osteomalacia, and osteoporosis later in life . Several risk factors for hypovitaminosis D have been described in the literature, including nutrition, little exposure to ultraviolet light, darker skin pigmentation, and lack of physical activity .

Lumbar isthmic spondylolysis is a stress fracture of the pars interarticularis, which is generally considered a disease of adolescents and young adults .

The exact prevalence of spondylolysis in our region is not exactly known, but the general impression among spine surgeons is that it is much higher than the 3-6% prevalence reported for the Caucasian population .

Spondylolysis commonly affects children and young adults . The exact etiology of this fatigue fracture of the pars interarticularis is still not well understood . The most probable mechanism of lumbar spondylolysis is multifactoral with a stress fracture occurring through a weak or dysplastic pars interarticularis. The likely initiating event occurs when the patient engages in repeated extension and/or axial rotation maneuvers .

Vitamin D deficiency may be a predisposing factor to weak bone and subsequent fractures . Despite abundant sunshine, hypovitaminosis D is very common in the Middle East Region and several cross- sectional studies in Egypt , Iran , Tunisia , Jordan , United Arab Emirates, and other Gulf countries have been reported. Symptomatic spondylolysis is indicated for surgical intervention.

Currently, children and adolescents with spondylolysis are treated with pars reconstruction techniques. Adults with symptomatic isthmic spondylolysis or with large defects are treated with spinal fusion.

The hypothesis of this study is that hypovitaminosis D predisposes to weakness of the pars interarticularis and subsequently is a risk factor for developing isthmic spondylolysis. Given the common incidence of hypovitaminosis D in Egyptian population and the negative impact of spondylolysis on the young active age group, this study would have important implications regarding prophylactic vitamin D supplementation as well as the prevention of spondylolysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients: Adults aged 20 - 45 years with symptomatic isthmic spondylolysis

• Controls: Matched population without spondylolysis indicated for plain x-ray and CT lumbo-sacral spine. These will be recruited mainly from the Trauma Unit. This will not add any non-indicated radiation exposure to healthy individuals

Exclusion Criteria:

• Traumatic spondylolysis

• Pregnant women

• Significant co-morbidities (renal or hepatic diseases, malignancy, malabsorption syndrome, musculoskeletal diseases, steroid therapy)

• Metabolic diseases affecting vitamin D and Calcium metabolism (e.g. hyperparathyroidism)

Related Conditions & MeSH terms

• Spondylolysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (22)

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McClellan JW 3rd, Vernon BA, White MA, Stamm S, Ryschon KL. Should 25-hydroxyvitamin D and bone density using DXA be tested in adolescents with lumbar stress fractures of the pars interarticularis? J Spinal Disord Tech. 2012 Dec;25(8):426-8. doi: 10.1097/BSD.0b013e31823f324f. — View Citation

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Saraste H. Long-term clinical and radiological follow-up of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1987 Nov-Dec;7(6):631-8. — View Citation

Virta L, Ronnemaa T, Osterman K, Aalto T, Laakso M. Prevalence of isthmic lumbar spondylolisthesis in middle-aged subjects from eastern and western Finland. J Clin Epidemiol. 1992 Aug;45(8):917-22. doi: 10.1016/0895-4356(92)90075-x. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean serum vitamin D in both groups.	Patients will be classified, according to the Endocrine Society guidelines for 2011, into vitamin D deficient if serum 25 is =20 ng/dl, vitamin D insufficient if it is 21-29 ng/dl and vitamin D sufficient if it is =30 ng/dl [8].	Baseline
Secondary	Mean serum calcium level	Mean serum Calcium level in both groups.	Baseline