跳至主要内容
临床试验/NCT06284967
NCT06284967尚未招募不适用

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

Assiut University0 个研究点目标入组 184 人开始时间: 2024年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
184
主要终点
Mean serum vitamin D in both groups.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Mean serum vitamin D in both groups.

时间窗: Baseline

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 \[8\].

次要结局

  • Mean serum calcium level(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina Emad Zakaria Nasif

Principal investigator

Assiut University

相似试验