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

Not Applicable

Completed

• Conditions: Vitamin D; Lumbar Spine Disease; Spinal Fusion
• Interventions: Dietary Supplement: vitamin D3; Dietary Supplement: calcium

• Registration Number: NCT05023122
• Lead Sponsor: Show Chwan Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-08
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D3 + calcium	vitamin D3	vitamin D3 (cholecalciferol) 800 IU QD and calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
vitamin D3 + calcium	calcium	vitamin D3 (cholecalciferol) 800 IU QD and calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months
calcium only	calcium	only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months

Primary Outcome Measures

Name	Time	Method
fusion rate at postoperative 1 year	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

Name	Time	Method
spine function at postoperative 6 months	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	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	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).
time to fusion	from postoperative day 1 to postoperative 1 year	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	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.

Trial Locations

Locations (1)

Show Chwan Memorial Hospital; 🇨🇳 Changhua City, Changhua, Taiwan