Association Of Serum Vitamin D Level With Isthmic Spondylolysis

March 7, 2024 updated by: Mina Emad Zakaria Nasif, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mina Emad Zakaria Nasif, R. Doctor
  • Phone Number: 01220033831
  • Email: me3049585@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Detailed history taking (including dietary calcium and vitamin D intakes, Exposure to sun, and Clothing habits)

  • Clinical examination
  • Imaging: plain x-ray and CT scan
  • Laboratory: Free serum calcium, alkaline phosphatase and 25-OH vitamin D

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean serum vitamin D in both groups.
Time Frame: 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].
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean serum calcium level
Time Frame: Baseline
Mean serum Calcium level in both groups.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mahmoud Fouad Ibrahim, Doctor, Assiut University
  • Study Director: Ahmed Shawky Abdelgawaad, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D In Spondylolysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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