The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Primary Purpose
Vitamin D, Spinal Fusion, Lumbar Spine Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
vitamin D3
calcium
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D
Eligibility Criteria
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
Sites / Locations
- Show Chwan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vitamin D3 + calcium
calcium only
Arm Description
vitamin D3 (cholecalciferol) 800 IU QD and calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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).
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).
Full Information
NCT ID
NCT05023122
First Posted
August 20, 2021
Last Updated
August 20, 2021
Sponsor
Show Chwan Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05023122
Brief Title
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Official Title
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Show Chwan Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D, Spinal Fusion, Lumbar Spine Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3 + calcium
Arm Type
Experimental
Arm Description
vitamin D3 (cholecalciferol) 800 IU QD and calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
Arm Title
calcium only
Arm Type
Active Comparator
Arm Description
only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Intervention Description
vitamin D3 (cholecalciferol) 800 IU QD
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium
Intervention Description
calcium citrate 600 mg QD
Primary Outcome Measure Information:
Title
fusion rate at postoperative 1 year
Description
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.
Time Frame
postoperative 1 year
Secondary Outcome Measure Information:
Title
time to fusion
Description
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
Time Frame
from postoperative day 1 to postoperative 1 year
Title
spine function at postoperative 3 months
Description
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.
Time Frame
postoperative 3 months
Title
spine function at postoperative 6 months
Description
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.
Time Frame
postoperative 6 months
Title
pain at postoperative 3 months
Description
Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain).
Time Frame
postoperative 3 months
Title
pain at postoperative 6 months
Description
Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain).
Time Frame
postoperative 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yuan Lee, MD, PhD
Organizational Affiliation
Show Chwan Memorial Hospital, Changhua, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36401234
Citation
Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.
Results Reference
derived
Learn more about this trial
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
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