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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05023122
Other study ID # RD105014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2018

Study information

Verified date August 2021
Source Show Chwan Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
vitamin D3
vitamin D3 (cholecalciferol) 800 IU QD
calcium
calcium citrate 600 mg QD

Locations

Country Name City State
Taiwan Show Chwan Memorial Hospital Changhua City Changhua

Sponsors (1)

Lead Sponsor Collaborator
Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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