<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03820895</url>
  </required_header>
  <id_info>
    <org_study_id>vit d in AIS</org_study_id>
    <nct_id>NCT03820895</nct_id>
  </id_info>
  <brief_title>Vitamin D Levels in Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>Assessment of Serum Vitamin D Levels in Surgical Adolescent Idiopathic Scoliosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Security Forces Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Security Forces Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to estimate the prevalence of vitamin D insufficiency among patients with&#xD;
      adolescent idiopathic scoliosis, to calculate the differences in serum vitamin D levels, Cobb&#xD;
      angles, spinal bone mass densities, and serum alkaline phosphatase levels between genders in&#xD;
      the sample, and to assess the possibility of a correlation between any of these factors in&#xD;
      those surgical patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent Idiopathic Scoliosis (AIS) is a major public health problem and despite its&#xD;
      relative rareness, it reduces the quality of life. It is three-dimensional deformity where&#xD;
      there is a lateral curving of the spine. The prevalence rate is 0.47-5.2%. The degree of the&#xD;
      spinal curvature is evaluated by the Cobb angle. A Cobb angle of more than 10-15° is&#xD;
      considered pathological. AIS occurs mostly in adolescents between 10 and 25 years of age, and&#xD;
      is more prevalent among females.&#xD;
&#xD;
      Scoliosis is considered severe and requires surgical intervention when the Cobb angle exceeds&#xD;
      40o.&#xD;
&#xD;
      The etiology of AIS is still unknown. Genetic and non-genetic factors have been attributed to&#xD;
      cause AIS. Among non-genetic factors is bone mineral density (BMD), as bone quality plays an&#xD;
      important role in the derangement of bony mechanical stability. The prevalence of AIS with&#xD;
      osteoporosis is approximately 20-38%. Osteoporosis is known to lower the bone strength.&#xD;
&#xD;
      Vitamin D plays an essential role in maintaining a healthy mineralized skeleton. It helps&#xD;
      with calcium absorption, and patients with a deficiency of Vitamin D can have difficulties in&#xD;
      producing new bone and maintaining their bone strength.&#xD;
&#xD;
      In this study, the prevalence of vitamin D insufficiency among patients with AIS was&#xD;
      evaluated. Gender differences in serum vitamin D levels, Cobb angles, BMD, and serum alkaline&#xD;
      phosphatase levels were measured. Further correlation of Vitamin D with Cobb angles, BMD, and&#xD;
      serum ALP levels was also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measure vitamin D level in AIS patients</measure>
    <time_frame>Baseline</time_frame>
    <description>Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>calculate Cobb's angle in AIS patients</measure>
    <time_frame>Baseline</time_frame>
    <description>done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measure BMD values in AIS patients</measure>
    <time_frame>Baseline</time_frame>
    <description>were taken from the spine only by the use of a dual energy x-ray absorptiometry (DXA) scanner (Lunar, General Electric (GE) medical systems, UK)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measure Serum alkaline phosphatase (ALK) in AIS patients</measure>
    <time_frame>Baseline</time_frame>
    <description>measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Scoliosis Idiopathic</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>BMD</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA). Cobb's angle measurement was done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.</description>
    <other_name>X-ray</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient who suffer from AIS and are eligible for corrective surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AIS patients of either gender&#xD;
&#xD;
          -  Aged between 10-25 years old&#xD;
&#xD;
          -  Had Cobb angles of 40o or more (i.e. requiring corrective surgery)&#xD;
&#xD;
          -  Had their serum vitamin D levels measured prior to their corrective surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with non-idiopathic scoliosis (such as congenital or neuromuscular condition)&#xD;
&#xD;
          -  Younger than 10 years&#xD;
&#xD;
          -  Older than 25 years of age&#xD;
&#xD;
          -  Who did not have their serum vitamin D levels present on the system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
  </eligibility>
  <reference>
    <citation>Nowak R, Szota J, Mazurek U. Vitamin D receptor gene (VDR) transcripts in bone, cartilage, muscles and blood and microarray analysis of vitamin D responsive genes expression in paravertebral muscles of juvenile and adolescent idiopathic scoliosis patients. BMC Musculoskelet Disord. 2012 Dec 23;13:259. doi: 10.1186/1471-2474-13-259.</citation>
    <PMID>23259508</PMID>
  </reference>
  <results_reference>
    <citation>Gozdzialska A, Jaskiewicz J, Knapik-Czajka M, Drag J, Gawlik M, Ciesla M, Kulis A, Zarzycki D, Lipik E. Association of Calcium and Phosphate Balance, Vitamin D, PTH, and Calcitonin in Patients With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Apr;41(8):693-7. doi: 10.1097/BRS.0000000000001286.</citation>
    <PMID>27064335</PMID>
  </results_reference>
  <results_reference>
    <citation>Konieczny MR, Senyurt H, Krauspe R. Epidemiology of adolescent idiopathic scoliosis. J Child Orthop. 2013 Feb;7(1):3-9. doi: 10.1007/s11832-012-0457-4. Epub 2012 Dec 11.</citation>
    <PMID>24432052</PMID>
  </results_reference>
  <results_reference>
    <citation>Al-Arjani AM, Al-Sebai MW, Al-Khawashki HM, Saadeddin MF. Epidemiological patterns of scoliosis in a spinal center in Saudi Arabia. Saudi Med J. 2000 Jun;21(6):554-7.</citation>
    <PMID>11500705</PMID>
  </results_reference>
  <results_reference>
    <citation>Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.</citation>
    <PMID>25269032</PMID>
  </results_reference>
  <results_reference>
    <citation>Adobor RD, Joranger P, Steen H, Navrud S, Brox JI. A health economic evaluation of screening and treatment in patients with adolescent idiopathic scoliosis. Scoliosis. 2014 Dec 6;9(1):21. doi: 10.1186/s13013-014-0021-8. eCollection 2014.</citation>
    <PMID>25601889</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee WT, Cheung CS, Tse YK, Guo X, Qin L, Lam TP, Ng BK, Cheng JC. Association of osteopenia with curve severity in adolescent idiopathic scoliosis: a study of 919 girls. Osteoporos Int. 2005 Dec;16(12):1924-32. doi: 10.1007/s00198-005-1964-7. Epub 2005 Sep 15.</citation>
    <PMID>16163440</PMID>
  </results_reference>
  <results_reference>
    <citation>Al-Othman A, Al-Musharaf S, Al-Daghri NM, Krishnaswamy S, Yusuf DS, Alkharfy KM, Al-Saleh Y, Al-Attas OS, Alokail MS, Moharram O, Sabico S, Chrousos GP. Effect of physical activity and sun exposure on vitamin D status of Saudi children and adolescents. BMC Pediatr. 2012 Jul 3;12:92. doi: 10.1186/1471-2431-12-92.</citation>
    <PMID>22759399</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Security Forces Hospital</investigator_affiliation>
    <investigator_full_name>Raheef Alatassi</investigator_full_name>
    <investigator_title>Orthopedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>Cobb angle</keyword>
  <keyword>alkaline phosphatase</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820895
org study id: vit d in AIS
nct id: NCT03820895
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to estimate the prevalence of vitamin D insufficiency among patients with
      adolescent idiopathic scoliosis, to calculate the differences in serum vitamin D levels, Cobb
      angles, spinal bone mass densities, and serum alkaline phosphatase levels between genders in
      the sample, and to assess the possibility of a correlation between any of these factors in
      those surgical patients.
Adolescent Idiopathic Scoliosis (AIS) is a major public health problem and despite its
      relative rareness, it reduces the quality of life. It is three-dimensional deformity where
      there is a lateral curving of the spine. The prevalence rate is 0.47-5.2%. The degree of the
      spinal curvature is evaluated by the Cobb angle. A Cobb angle of more than 10-15° is
      considered pathological. AIS occurs mostly in adolescents between 10 and 25 years of age, and
      is more prevalent among females.

      Scoliosis is considered severe and requires surgical intervention when the Cobb angle exceeds
      40o.

      The etiology of AIS is still unknown. Genetic and non-genetic factors have been attributed to
      cause AIS. Among non-genetic factors is bone mineral density (BMD), as bone quality plays an
      important role in the derangement of bony mechanical stability. The prevalence of AIS with
      osteoporosis is approximately 20-38%. Osteoporosis is known to lower the bone strength.

      Vitamin D plays an essential role in maintaining a healthy mineralized skeleton. It helps
      with calcium absorption, and patients with a deficiency of Vitamin D can have difficulties in
      producing new bone and maintaining their bone strength.

      In this study, the prevalence of vitamin D insufficiency among patients with AIS was
      evaluated. Gender differences in serum vitamin D levels, Cobb angles, BMD, and serum alkaline
      phosphatase levels were measured. Further correlation of Vitamin D with Cobb angles, BMD, and
      serum ALP levels was also evaluated.
observational model: Cohort
time perspective: Retrospective
measure: measure vitamin D level in AIS patients
time frame: Baseline
description: Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA).
measure: calculate Cobb's angle in AIS patients
time frame: Baseline
description: done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.
measure: measure BMD values in AIS patients
time frame: Baseline
description: were taken from the spine only by the use of a dual energy x-ray absorptiometry (DXA) scanner (Lunar, General Electric (GE) medical systems, UK)
measure: measure Serum alkaline phosphatase (ALK) in AIS patients
time frame: Baseline
description: measured using a biochemical auto-analyzer (Siemens health diagnostics, USA).
intervention type: Diagnostic Test
intervention name: Blood test
description: Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA). Cobb's angle measurement was done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.
other name: X-ray
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 25 Years
citation: Nowak R, Szota J, Mazurek U. Vitamin D receptor gene (VDR) transcripts in bone, cartilage, muscles and blood and microarray analysis of vitamin D responsive genes expression in paravertebral muscles of juvenile and adolescent idiopathic scoliosis patients. BMC Musculoskelet Disord. 2012 Dec 23;13:259. doi: 10.1186/1471-2474-13-259.
PMID: 23259508
citation: Gozdzialska A, Jaskiewicz J, Knapik-Czajka M, Drag J, Gawlik M, Ciesla M, Kulis A, Zarzycki D, Lipik E. Association of Calcium and Phosphate Balance, Vitamin D, PTH, and Calcitonin in Patients With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Apr;41(8):693-7. doi: 10.1097/BRS.0000000000001286.
PMID: 27064335
citation: Konieczny MR, Senyurt H, Krauspe R. Epidemiology of adolescent idiopathic scoliosis. J Child Orthop. 2013 Feb;7(1):3-9. doi: 10.1007/s11832-012-0457-4. Epub 2012 Dec 11.
PMID: 24432052
citation: Al-Arjani AM, Al-Sebai MW, Al-Khawashki HM, Saadeddin MF. Epidemiological patterns of scoliosis in a spinal center in Saudi Arabia. Saudi Med J. 2000 Jun;21(6):554-7.
PMID: 11500705
citation: Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.
PMID: 25269032
citation: Adobor RD, Joranger P, Steen H, Navrud S, Brox JI. A health economic evaluation of screening and treatment in patients with adolescent idiopathic scoliosis. Scoliosis. 2014 Dec 6;9(1):21. doi: 10.1186/s13013-014-0021-8. eCollection 2014.
PMID: 25601889
citation: Lee WT, Cheung CS, Tse YK, Guo X, Qin L, Lam TP, Ng BK, Cheng JC. Association of osteopenia with curve severity in adolescent idiopathic scoliosis: a study of 919 girls. Osteoporos Int. 2005 Dec;16(12):1924-32. doi: 10.1007/s00198-005-1964-7. Epub 2005 Sep 15.
PMID: 16163440
citation: Al-Othman A, Al-Musharaf S, Al-Daghri NM, Krishnaswamy S, Yusuf DS, Alkharfy KM, Al-Saleh Y, Al-Attas OS, Alokail MS, Moharram O, Sabico S, Chrousos GP. Effect of physical activity and sun exposure on vitamin D status of Saudi children and adolescents. BMC Pediatr. 2012 Jul 3;12:92. doi: 10.1186/1471-2431-12-92.
PMID: 22759399
responsible party type: Principal Investigator
investigator affiliation: Security Forces Hospital
investigator full name: Raheef Alatassi
investigator title: Orthopedic Surgeon
mesh term: Scoliosis
mesh term: Vitamin D Deficiency
sharing ipd: Undecided