The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion

Study Overview
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Brief Summary
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The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.

Official Title
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The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion

Conditions
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Vitamin D, Spinal Fusion, Lumbar Spine Disease

Intervention / Treatment
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* Dietary Supplement: vitamin D3
* Dietary Supplement: calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 80 years Indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from January 2016 to December 2017. Exclusion Criteria: Spinal instability due to trauma, infection, or malignancy History of previous spine surgery Hemodialysis Long-term steroid use History of medical treatments for osteoporosis Postoperative follow-up for less than 12 months Newly-onset compression fracture after study procedure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3 + calcium<br>vitamin D3 (cholecalciferol) 800 IU QD and calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months | Dietary Supplement: vitamin D3<br>* vitamin D3 (cholecalciferol) 800 IU QD<br>Dietary Supplement: calcium<br>* calcium citrate 600 mg QD<br>|
| Active Comparator: calcium only<br>only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months | Dietary Supplement: calcium<br>* calcium citrate 600 mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fusion rate at postoperative 1 year | Fusion status were assessed by radiography and computed tomography of the lumbar spine. Fusion was defined as the presence of bridging callus without radiolucent line, spinal range of motion between two fused vertebrae less than 5 degrees, and no implant loosening or failure on lumbar spine radiography. | postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to fusion | Time to fusion were assessed by radiography and computed tomography (CT) of the lumbar spine.Fusion was defined as the presence of bridging callus without radiolucent line, spinal range of motion between two fused vertebrae less than 5 degrees, and no implant loosening or failure on lumbar spine radiography | from postoperative day 1 to postoperative 1 year | 
| spine function at postoperative 3 months | Spine function was evaluated using Oswestry Disability Index (ODI), which contains 10 patient-completed questions addressing spinal function. Each question is presented as 6-point Likert scales from 0 to 5 (0 = best outcome, 5 = worst outcome). The overall ODI score ranges from 0% to 100% and a lower score indicates better function. | postoperative 3 months | 
| spine function at postoperative 6 months | Spine function was evaluated using Oswestry Disability Index (ODI), which contains 10 patient-completed questions addressing spinal function. Each question is presented as 6-point Likert scales from 0 to 5 (0 = best outcome, 5 = worst outcome). The overall ODI score ranges from 0% to 100% and a lower score indicates better function. | postoperative 6 months | 
| pain at postoperative 3 months | Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain). | postoperative 3 months | 
| pain at postoperative 6 months | Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain). | postoperative 6 months |