Hypovitaminosis DNCT02534714
Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016
An observational study of Hypovitaminosis D and Spinal Disease, run by OSF Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypovitaminosis D, Spinal Disease, Osteoporosis
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (Part 1, Retrospective Study) - patients diagnosed with any form of spinal disease who underwent spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from November 1, 2012 to October 31, 2014 who had a serum vitamin D level collected as standard of care prior to surgery. (Part 2, Prospective Study) - patients diagnosed with any form of spinal disease that underwent cervical, thoracic, and/or lumbar spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from July 1, 2015 to June 30, 2016 who had a serum vitamin D level and bone marrow density scan collected as standard of care prior to surgery.
Who may be able to join
- 50 years old or older.
- Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014.
- 50 years old or older.
- Serum Vitamin D level checked prior to or at surgery.
- BMD exam performed anytime within 2 years prior to surgery.
- Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016.
Who cannot join
- Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery.
- (Part 2, Observational Study)
- (Screening period July 1, 2015-June 30, 2016)
- Subjects diagnosed with:
- Chronic Renal Disease with a GFR < 45 at Stage IV
- Metastatic Spinal Disease
Show all 9Show fewer
- Bariatric surgery
- Seizure medication
- Chronic steroid use greater than 3 months at time of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Read the detailed description
Bone Health is becoming of great concern in the population > 50 years old in the past several decades. Literature review has detected a high incidence of patients with hypovitaminosis D and back pain. Vitamin D Deficiency is in all races, age groups, and ethnic backgrounds affecting greater than one billion people worldwide1. There is a higher incidence of Vitamin D Deficiency noted in the northern states.
Adequate Vitamin D is essential in bone health and muscle function. It also has been reported to have positive effects on decreasing myopathy and /or musculoskeletal pain. Vitamin D has been shown to have a protective effect on fracture risk by providing increased bone matrix and on fall prevention through improved muscle function. 2
Deficiency of this vitamin can lead to impaired bone mineralization and bone softening diseases including osteomalacia and osteoporosis in adults. Osteomalacia has significant risk factors for vertebral fractures, and spinal instrumentation failure. Low-energy fractures or fragility fractures have been found to be more common because of an increase in life expectancy 3. The total 25-hydroxyvitamin D (25-OH-VitD) level (the sum of 25-OH-vitamin D2 and 25-OH-vitamin D3) is the appropriate indicator of vitamin D body stores. Presently, there is no universal consensus about a treatment cut point. Studies suggest >30 ng/mL as the minimal concentration of 25-OH-Vit D Total is needed to avoid the adverse effects of deficiency4. Vitamin D insufficiency is considered at <30ng/ml to 21 ng/ml and Vitamin D Deficiency is <20 ng/ml of 25-OH-Vit D Total. Several researches have indicated increasing Vitamin D levels >45 ng/ml will increase their immune system, bone health, lower risks of neurological disorders and cancers. 3,4
Influential pathophysiological changes in osteoporosis include the hyperactivity of osteoclasts compared to the need for bone remodeling or a decreased activity of osteoblasts compared to the need for bone cavity repair or laying down new bone.5 Osteoporosis has become synonymous with decreased bone mineral density (BMD). Bone Marrow Density scans (DXA) allows accurate diagnosis of osteoporosis, estimation of fracture risk, and monitoring of patients undergoing treatment.5 In postmenopausal women and men age 50 years and older, the WHO diagnostic T-score criteria categorizes a normal DXA scan of <1.0 or above, low bone mass or osteopenia has a T score between <1.0 and -2.5, and osteoporosis is designated with a T-score at -2.5 or below) are applied to BMD measurement by central DXA at the lumbar spine and femoral neck. 5
This study was done in two parts. Part 1 was the Retrospective Study from November 1, 2012 to October 31, 2014 and Part 2 is the Prospective pilot from July 1, 2015-June 30, 2016. We are anticipating to raise the awareness and identify the importance of evaluating for hypovitaminosis D and bone marrow density preoperatively in Neurosurgery Clinic for 12 months. Our goal is to show treating bone health in spinal diseased patients preoperatively will provide optimal bone health with better long term outcomes requiring less revision surgeries for our patients.
Research Question:
Part 1 - Retrospective Study
- What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
Part 2- Prospective Study (screening period July 1, 2015-June 30, 2016)
- What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
- Do patients with Hypovitaminosis D maintain therapeutic levels between 45 ng/ml to 75 ng/ml in approximately 3, 6, and 12 months postoperatively with supplements of Vitamin D3?
- What are the incidences of osteopenia and osteoporosis in elective spinal fusion patients based on a Dexascans in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
- Do the patients' demographic information, such as age, sex, BMI, and family history influence the outcome measures (Vitamin D deficiency, Osteopenia, and Osteoporosis)?
- Conditions
- Hypovitaminosis D, Spinal Disease, Osteoporosis
- Medical subject headings
- Vitamin D Deficiency, Spinal Diseases, Osteoporosis
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 |
|---|---|---|
| Retrospective (Part 1) Group | This is a retrospective pilot study in patients diagnosed with any form of spinal disease who underwent spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from November 1, 2012 to October 31, 2014. Only spinal fusion patients with a serum Vitamin D level prior to or at time of surgery and after surgery are included in this review. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The charts reviewed will belong to subjects who were closely followed at the OSF/INI clinic. | |
| Prospective (Part 2) Group | This is a prospective pilot study in subjects diagnosed with any form of spinal disease that underwent cervical, thoracic, and/or lumbar spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from July 1, 2015 to June 30, 2016. (Screening period July 1, 2015-June 30, 2016) Only spinal fusion patients with a serum Vitamin D level, and Bone Marrow Density prior to or at time of surgery are included in this study. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The subjects were closely followed at the OSF/INI clinic post-operatively at 3, 6, and 12 months. Pre-op Vitamin D level and Bone Marrow Density will be measured at the baseline, and again at 3, 6, and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level
Prospective Vitamin D lab of 25 Hydroxyvitamin D Total <30 ng/ml in the population >50 years old will have increased incidence of progressive spinal disease.
Measured: Within 30 days (pre-op)
(Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level
- Vitamin D values. We will categorize it to different levels: if the value is <30 ng/ml to 21 ng/ml-then it is insufficient; if the value is <20 ng/ml, then it is deficient.
Measured: Pre-op and at 3, 6, 12 months post-op
(Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA)
Categorized as normal, osteopenia, and osteoporosis
Measured: Within 2 years prior to spinal surgery
Secondary outcomes (4)
(Part 1) Demographics
Gender, Age, Ethnicity
Measured: Screening
(Part 1) Medical History
Medical History, BMI, smoking status, supplementation
Measured: Screening - immediately post-op
(Part 2) Demographics
Gender, Age, Ethnicity
Measured: Screening
(Part 2 ) Medical History
Family history osteoporosis, smoking status, calcium and vitamin D supplementation, and diabetes
Measured: Screening - 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria
- Responsible party
- Principal investigator, Jana Reed, OSF Healthcare System
- Investigators
- Todd McCall, MD, Study chair, OSF Saint Francis, Illinois Neurological InstituteJana Reed, APN, Principal investigator, OSF Saint Francis Medical Center, Illinois Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534714
- Sponsor's protocol ID
- 632002
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
PubMed 20926724Kim TH, Yoon JY, Lee BH, Jung HS, Park MS, Park JO, Moon ES, Kim HS, Lee HM, Moon SH. Changes in vitamin D status after surgery in female patients with lumbar spinal stenosis and its clinical significance. Spine (Phila Pa 1976). 2012 Oct 1;37(21):E1326-30. doi: 10.1097/BRS.0b013e318268ff05.
PubMed 22805343Dipaola CP, Bible JE, Biswas D, Dipaola M, Grauer JN, Rechtine GR. Survey of spine surgeons on attitudes regarding osteoporosis and osteomalacia screening and treatment for fractures, fusion surgery, and pseudoarthrosis. Spine J. 2009 Jul;9(7):537-44. doi: 10.1016/j.spinee.2009.02.005. Epub 2009 Mar 28.
PubMed 19328744Heaney RP. Vitamin D: how much do we need, and how much is too much? Osteoporos Int. 2000;11(7):553-5. doi: 10.1007/s001980070074. No abstract available.
PubMed 11069187Manolagas SC. Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev. 2000 Apr;21(2):115-37. doi: 10.1210/edrv.21.2.0395.
PubMed 10782361Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007 Aug;83(982):509-17. doi: 10.1136/pgmj.2007.057505.
PubMed 17675543
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016
- ClinicalTrials.gov ID
- NCT02534714
- Acronym / sponsor ID
- 632002
- Conditions
- Hypovitaminosis D, Spinal Disease, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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 purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Detailed description
Bone Health is becoming of great concern in the population > 50 years old in the past several decades. Literature review has detected a high incidence of patients with hypovitaminosis D and back pain. Vitamin D Deficiency is in all races, age groups, and ethnic backgrounds affecting greater than one billion people worldwide1. There is a higher incidence of Vitamin D Deficiency noted in the northern states.
Adequate Vitamin D is essential in bone health and muscle function. It also has been reported to have positive effects on decreasing myopathy and /or musculoskeletal pain. Vitamin D has been shown to have a protective effect on fracture risk by providing increased bone matrix and on fall prevention through improved muscle function. 2
Deficiency of this vitamin can lead to impaired bone mineralization and bone softening diseases including osteomalacia and osteoporosis in adults. Osteomalacia has significant risk factors for vertebral fractures, and spinal instrumentation failure. Low-energy fractures or fragility fractures have been found to be more common because of an increase in life expectancy 3. The total 25-hydroxyvitamin D (25-OH-VitD) level (the sum of 25-OH-vitamin D2 and 25-OH-vitamin D3) is the appropriate indicator of vitamin D body stores. Presently, there is no universal consensus about a treatment cut point. Studies suggest >30 ng/mL as the minimal concentration of 25-OH-Vit D Total is needed to avoid the adverse effects of deficiency4. Vitamin D insufficiency is considered at <30ng/ml to 21 ng/ml and Vitamin D Deficiency is <20 ng/ml of 25-OH-Vit D Total. Several researches have indicated increasing Vitamin D levels >45 ng/ml will increase their immune system, bone health, lower risks of neurological disorders and cancers. 3,4
Influential pathophysiological changes in osteoporosis include the hyperactivity of osteoclasts compared to the need for bone remodeling or a decreased activity of osteoblasts compared to the need for bone cavity repair or laying down new bone.5 Osteoporosis has become synonymous with decreased bone mineral density (BMD). Bone Marrow Density scans (DXA) allows accurate diagnosis of osteoporosis, estimation of fracture risk, and monitoring of patients undergoing treatment.5 In postmenopausal women and men age 50 years and older, the WHO diagnostic T-score criteria categorizes a normal DXA scan of <1.0 or above, low bone mass or osteopenia has a T score between <1.0 and -2.5, and osteoporosis is designated with a T-score at -2.5 or below) are applied to BMD measurement by central DXA at the lumbar spine and femoral neck. 5
This study was done in two parts. Part 1 was the Retrospective Study from November 1, 2012 to October 31, 2014 and Part 2 is the Prospective pilot from July 1, 2015-June 30, 2016. We are anticipating to raise the awareness and identify the importance of evaluating for hypovitaminosis D and bone marrow density preoperatively in Neurosurgery Clinic for 12 months. Our goal is to show treating bone health in spinal diseased patients preoperatively will provide optimal bone health with better long term outcomes requiring less revision surgeries for our patients.
Research Question:
Part 1 - Retrospective Study
- What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
Part 2- Prospective Study (screening period July 1, 2015-June 30, 2016)
- What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
- Do patients with Hypovitaminosis D maintain therapeutic levels between 45 ng/ml to 75 ng/ml in approximately 3, 6, and 12 months postoperatively with supplements of Vitamin D3?
- What are the incidences of osteopenia and osteoporosis in elective spinal fusion patients based on a Dexascans in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
- Do the patients' demographic information, such as age, sex, BMI, and family history influence the outcome measures (Vitamin D deficiency, Osteopenia, and Osteoporosis)?
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective (Part 1) Group | – | –This is a retrospective pilot study in patients diagnosed with any form of spinal disease who underwent spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from November 1, 2012 to October 31, 2014. Only spinal fusion patients with a serum Vitamin D level prior to or at time of surgery and after surgery are included in this review. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The charts reviewed will belong to subjects who were closely followed at the OSF/INI clinic. |
| Prospective (Part 2) Group | – | –This is a prospective pilot study in subjects diagnosed with any form of spinal disease that underwent cervical, thoracic, and/or lumbar spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from July 1, 2015 to June 30, 2016. (Screening period July 1, 2015-June 30, 2016) Only spinal fusion patients with a serum Vitamin D level, and Bone Marrow Density prior to or at time of surgery are included in this study. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The subjects were closely followed at the OSF/INI clinic post-operatively at 3, 6, and 12 months. Pre-op Vitamin D level and Bone Marrow Density will be measured at the baseline, and again at 3, 6, and 12 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (Part 1, Retrospective Study) - patients diagnosed with any form of spinal disease who underwent spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from November 1, 2012 to October 31, 2014 who had a serum vitamin D level collected as standard of care prior to surgery. (Part 2, Prospective Study) - patients diagnosed with any form of spinal disease that underwent cervical, thoracic, and/or lumbar spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from July 1, 2015 to June 30, 2016 who had a serum vitamin D level and bone marrow density scan collected as standard of care prior to surgery.
Key inclusion criteria (6 listed)
- 50 years old or older.
- Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014.
- 50 years old or older.
- Serum Vitamin D level checked prior to or at surgery.
- BMD exam performed anytime within 2 years prior to surgery.
Key exclusion criteria (9 listed)
- Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery.
- (Part 2, Observational Study)
- (Screening period July 1, 2015-June 30, 2016)
- Subjects diagnosed with:
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
(Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level
Time frame: Within 30 days (pre-op)
Prospective Vitamin D lab of 25 Hydroxyvitamin D Total <30 ng/ml in the population >50 years old will have increased incidence of progressive spinal disease.
(Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level
Time frame: Pre-op and at 3, 6, 12 months post-op
1. Vitamin D values. We will categorize it to different levels: if the value is <30 ng/ml to 21 ng/ml-then it is insufficient; if the value is <20 ng/ml, then it is deficient.
(Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA)
Time frame: Within 2 years prior to spinal surgery
Categorized as normal, osteopenia, and osteoporosis
4 secondary outcomes
(Part 1) Demographics
Time frame: Screening
(Part 1) Medical History
Time frame: Screening - immediately post-op
(Part 2) Demographics
Time frame: Screening
(Part 2 ) Medical History
Time frame: Screening - 12 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 20926724Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
- Background: PubMed 22805343Kim TH, Yoon JY, Lee BH, Jung HS, Park MS, Park JO, Moon ES, Kim HS, Lee HM, Moon SH. Changes in vitamin D status after surgery in female patients with lumbar spinal stenosis and its clinical significance. Spine (Phila Pa 1976). 2012 Oct 1;37(21):E1326-30. doi: 10.1097/BRS.0b013e318268ff05.
- Background: PubMed 19328744Dipaola CP, Bible JE, Biswas D, Dipaola M, Grauer JN, Rechtine GR. Survey of spine surgeons on attitudes regarding osteoporosis and osteomalacia screening and treatment for fractures, fusion surgery, and pseudoarthrosis. Spine J. 2009 Jul;9(7):537-44. doi: 10.1016/j.spinee.2009.02.005. Epub 2009 Mar 28.
- Background: PubMed 11069187Heaney RP. Vitamin D: how much do we need, and how much is too much? Osteoporos Int. 2000;11(7):553-5. doi: 10.1007/s001980070074. No abstract available.
- Background: PubMed 10782361Manolagas SC. Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev. 2000 Apr;21(2):115-37. doi: 10.1210/edrv.21.2.0395.
- Background: PubMed 17675543Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007 Aug;83(982):509-17. doi: 10.1136/pgmj.2007.057505.
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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.
Todd McCall, MD study chair
OSF Saint Francis, Illinois Neurological Institute
Jana Reed, APN principal investigator
OSF Saint Francis Medical Center, Illinois Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovitaminosis D and Spinal Disease, run by OSF Healthcare System at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level (time frame: Within 30 days (pre-op)). The study lists 3 primary outcomes in all. 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 NCT02534714, which also lists 6 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 28 Aug 2018.