NCT06284967

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

February 22, 2024

Last Update Submit

March 7, 2024

Conditions

Spondylolysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mean serum calcium level

    Baseline

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • 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.

    PMID: 22134731BACKGROUND

  • Chakhtoura 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.

    PMID: 29955632BACKGROUND

  • Bassil 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.

    PMID: 24194968BACKGROUND

  • Melamed 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.

    PMID: 20490283BACKGROUND

  • Prentice 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.

    PMID: 18689390BACKGROUND

  • Kalkwarf 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.

    PMID: 17311856BACKGROUND

  • Holick 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.

    PMID: 14985208BACKGROUND

  • Holick 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.

    PMID: 21646368BACKGROUND

  • Holick MF. Vitamin D: a d-lightful solution for health. J Investig Med. 2011 Aug;59(6):872-80. doi: 10.2310/JIM.0b013e318214ea2d.

    PMID: 21415774BACKGROUND

  • Fredrickson 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.

    PMID: 6373773BACKGROUND

  • 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.

    PMID: 1624974BACKGROUND

  • Albanese M, Pizzutillo PD. Family study of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1982;2(5):496-9. doi: 10.1097/01241398-198212000-00006.

    PMID: 6761366BACKGROUND

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

    PMID: 2963019BACKGROUND

  • Lawrence 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.

    PMID: 27234265BACKGROUND

  • Farouk 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.

    PMID: 27551573BACKGROUND

  • Botros RM, Sabry IM, Abdelbaky RS, Eid YM, Nasr MS, Hendawy LM. Vitamin D deficiency among healthy Egyptian females. Endocrinol Nutr. 2015 Aug-Sep;62(7):314-21. doi: 10.1016/j.endonu.2015.03.010. Epub 2015 Jun 10. English, Spanish.

    PMID: 26070223BACKGROUND

  • Hashemipour S, Larijani B, Adibi H, Javadi E, Sedaghat M, Pajouhi M, Soltani A, Shafaei AR, Hamidi Z, Fard AR, Hossein-Nezhad A, Booya F. Vitamin D deficiency and causative factors in the population of Tehran. BMC Public Health. 2004 Aug 25;4:38. doi: 10.1186/1471-2458-4-38.

    PMID: 15327695BACKGROUND

  • Meddeb N, Sahli H, Chahed M, Abdelmoula J, Feki M, Salah H, Frini S, Kaabachi N, Belkahia Ch, Mbazaa R, Zouari B, Sellami S. Vitamin D deficiency in Tunisia. Osteoporos Int. 2005 Feb;16(2):180-3. doi: 10.1007/s00198-004-1658-6. Epub 2004 Jun 10.

    PMID: 15197539BACKGROUND

  • Mishal AA. Effects of different dress styles on vitamin D levels in healthy young Jordanian women. Osteoporos Int. 2001;12(11):931-5. doi: 10.1007/s001980170021.

    PMID: 11804019BACKGROUND

  • Lips P, Hosking D, Lippuner K, Norquist JM, Wehren L, Maalouf G, Ragi-Eis S, Chandler J. The prevalence of vitamin D inadequacy amongst women with osteoporosis: an international epidemiological investigation. J Intern Med. 2006 Sep;260(3):245-54. doi: 10.1111/j.1365-2796.2006.01685.x.

    PMID: 16918822BACKGROUND

  • Saadi HF, Nagelkerke N, Benedict S, Qazaq HS, Zilahi E, Mohamadiyeh MK, Al-Suhaili AI. Predictors and relationships of serum 25 hydroxyvitamin D concentration with bone turnover markers, bone mineral density, and vitamin D receptor genotype in Emirati women. Bone. 2006 Nov;39(5):1136-1143. doi: 10.1016/j.bone.2006.05.010. Epub 2006 Jun 30.

    PMID: 16814623BACKGROUND

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND

MeSH Terms

Conditions

Spondylolysis

Condition Hierarchy (Ancestors)

SpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Ahmed Shawky Abdelgawaad, Professor

    Assiut University

    STUDY DIRECTOR

  • Mahmoud Fouad Ibrahim, Doctor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Emad Zakaria Nasif, R. Doctor

CONTACT

01220033831me3049585@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

March 8, 2024

Record last verified: 2024-03