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

Show Chwan Memorial Hospital

Status: Completed

Conditions: Spinal Fusion; Vitamin D; Lumbar Spine Disease

Treatments: Dietary Supplement: calcium; Dietary Supplement: vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05023122

RD105014

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

vitamin D3 + calcium

Experimental group

Description:

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

Treatment:

Dietary Supplement: calcium

Dietary Supplement: vitamin D3

calcium only

Active Comparator group

Description:

only calcium citrate 600 mg QD, given from postoperative day 1 and lasted for 3 months

Treatment:

Dietary Supplement: calcium