SpondylolysisNCT06284967
Association Of Serum Vitamin D Level With Isthmic Spondylolysis
An observational study of Spondylolysis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Spondylolysis
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spondylolysis
- Medical subject headings
- Spondylolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Baseline
Secondary outcomes (1)
Mean serum calcium level
Mean serum Calcium level in both groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startMar 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for SpondylolysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Emad Zakaria Nasif, Assiut University
- Investigators
- Ahmed Shawky Abdelgawaad, Professor, Study director, Assiut UniversityMahmoud Fouad Ibrahim, Doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284967
- Sponsor's protocol ID
- Vitamin D In Spondylolysis
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22134731Chakhtoura M, Rahme M, Chamoun N, El-Hajj Fuleihan G. Vitamin D in the Middle East and North Africa. Bone Rep. 2018 Mar 17;8:135-146. doi: 10.1016/j.bonr.2018.03.004. eCollection 2018 Jun.
PubMed 29955632Bassil D, Rahme M, Hoteit M, Fuleihan Gel-H. Hypovitaminosis D in the Middle East and North Africa: Prevalence, risk factors and impact on outcomes. Dermatoendocrinol. 2013 Apr 1;5(2):274-98. doi: 10.4161/derm.25111.
PubMed 24194968Melamed ML, Kumar J. Low levels of 25-hydroxyvitamin D in the pediatric populations: prevalence and clinical outcomes. Ped Health. 2010 Feb;4(1):89-97. doi: 10.2217/phe.09.72.
PubMed 20490283Prentice A, Goldberg GR, Schoenmakers I. Vitamin D across the lifecycle: physiology and biomarkers. Am J Clin Nutr. 2008 Aug;88(2):500S-506S. doi: 10.1093/ajcn/88.2.500S.
PubMed 18689390Kalkwarf HJ, Zemel BS, Gilsanz V, Lappe JM, Horlick M, Oberfield S, Mahboubi S, Fan B, Frederick MM, Winer K, Shepherd JA. The bone mineral density in childhood study: bone mineral content and density according to age, sex, and race. J Clin Endocrinol Metab. 2007 Jun;92(6):2087-99. doi: 10.1210/jc.2006-2553. Epub 2007 Feb 20.
PubMed 17311856Holick MF. Vitamin D: importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis. Am J Clin Nutr. 2004 Mar;79(3):362-71. doi: 10.1093/ajcn/79.3.362.
PubMed 14985208Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
PubMed 21646368Holick MF. Vitamin D: a d-lightful solution for health. J Investig Med. 2011 Aug;59(6):872-80. doi: 10.2310/JIM.0b013e318214ea2d.
PubMed 21415774Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP. The natural history of spondylolysis and spondylolisthesis. J Bone Joint Surg Am. 1984 Jun;66(5):699-707.
PubMed 6373773Virta 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.
PubMed 1624974Albanese M, Pizzutillo PD. Family study of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1982;2(5):496-9. doi: 10.1097/01241398-198212000-00006.
PubMed 6761366Saraste H. Long-term clinical and radiological follow-up of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1987 Nov-Dec;7(6):631-8.
PubMed 2963019Lawrence KJ, Elser T, Stromberg R. Lumbar spondylolysis in the adolescent athlete. Phys Ther Sport. 2016 Jul;20:56-60. doi: 10.1016/j.ptsp.2016.04.003. Epub 2016 Apr 13.
PubMed 27234265Farouk O, Mahran DG, Said HG, Alaa MM, Eisa AA, Said GZ, Rashed H, Ez-Eldeen A. Hypovitaminosis D Among Patients Admitted With Hip Fracture to a Level-1 Trauma Center in the Sunny Upper Egypt: Prevalence and Associated Correlates. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):148-52. doi: 10.1177/2151458516655436. Epub 2016 Jun 22.
PubMed 27551573
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study On Association Of Serum Vitamin D Level With Isthmic Spondylolysis In Adult Population
- ClinicalTrials.gov ID
- NCT06284967
- Acronym / sponsor ID
- Vitamin D In Spondylolysis
- Conditions
- Spondylolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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].
1 secondary outcome
Mean serum calcium level
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 22134731McClellan 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.
- Background: PubMed 29955632Chakhtoura M, Rahme M, Chamoun N, El-Hajj Fuleihan G. Vitamin D in the Middle East and North Africa. Bone Rep. 2018 Mar 17;8:135-146. doi: 10.1016/j.bonr.2018.03.004. eCollection 2018 Jun.
- Background: PubMed 24194968Bassil D, Rahme M, Hoteit M, Fuleihan Gel-H. Hypovitaminosis D in the Middle East and North Africa: Prevalence, risk factors and impact on outcomes. Dermatoendocrinol. 2013 Apr 1;5(2):274-98. doi: 10.4161/derm.25111.
- Background: PubMed 20490283Melamed ML, Kumar J. Low levels of 25-hydroxyvitamin D in the pediatric populations: prevalence and clinical outcomes. Ped Health. 2010 Feb;4(1):89-97. doi: 10.2217/phe.09.72.
- Background: PubMed 18689390Prentice A, Goldberg GR, Schoenmakers I. Vitamin D across the lifecycle: physiology and biomarkers. Am J Clin Nutr. 2008 Aug;88(2):500S-506S. doi: 10.1093/ajcn/88.2.500S.
- Background: PubMed 17311856Kalkwarf HJ, Zemel BS, Gilsanz V, Lappe JM, Horlick M, Oberfield S, Mahboubi S, Fan B, Frederick MM, Winer K, Shepherd JA. The bone mineral density in childhood study: bone mineral content and density according to age, sex, and race. J Clin Endocrinol Metab. 2007 Jun;92(6):2087-99. doi: 10.1210/jc.2006-2553. Epub 2007 Feb 20.
- Background: PubMed 14985208Holick MF. Vitamin D: importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis. Am J Clin Nutr. 2004 Mar;79(3):362-71. doi: 10.1093/ajcn/79.3.362.
- Background: PubMed 21646368Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
- Background: PubMed 21415774Holick MF. Vitamin D: a d-lightful solution for health. J Investig Med. 2011 Aug;59(6):872-80. doi: 10.2310/JIM.0b013e318214ea2d.
- Background: PubMed 6373773Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP. The natural history of spondylolysis and spondylolisthesis. J Bone Joint Surg Am. 1984 Jun;66(5):699-707.
- Background: PubMed 1624974Virta 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.
- Background: PubMed 6761366Albanese M, Pizzutillo PD. Family study of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1982;2(5):496-9. doi: 10.1097/01241398-198212000-00006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Shawky Abdelgawaad, Professor study director
Assiut University
Mahmoud Fouad Ibrahim, Doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolysis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Emad Zakaria Nasif, R. Doctor (01220033831, me3049585@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean serum vitamin D in both groups. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284967, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.