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

• Sponsor: Show Chwan Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05023122
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D; Spinal Fusion; Lumbar Spine Disease	Dietary Supplement: vitamin D3; Dietary Supplement: calcium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vitamin D3 + calcium 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; vitamin D3 (cholecalciferol) 800 IU QD; Dietary Supplement: calcium; calcium citrate 600 mg QD
Active Comparator: calcium only only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months	Dietary Supplement: calcium; calcium citrate 600 mg QD

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. 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.

4. 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).

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Show Chwan Memorial Hospital	Changhua City	Changhua	Taiwan	500

Sponsors and Collaborators

• Show Chwan Memorial Hospital

Investigators

• Study Director: Pei-Yuan Lee, MD, PhD, Show Chwan Memorial Hospital, Changhua, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pei-Yuan Lee, MD, Honorary President, Show Chwan Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05023122
• Other Study ID Numbers: RD105014
• First Posted: Aug 26, 2021
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Diseases; Vitamin D; Cholecalciferol; Calcium

Study Results

No Results Posted as of Aug 26, 2021