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Completed

NCT Number: NCT05023122

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

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.

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Key information

Conditions

Vitamin D Bone Diseases Lumbar Spine Disease Musculoskeletal Diseases Spinal Diseases Spinal Fusion

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

vitamin D3 (cholecalciferol) 800 IU QD

Calcium

Dietary Supplement

calcium citrate 600 mg QD

Primary outcomes

  1. fusion rate at postoperative 1 year

    Time frame: 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 outcomes

  1. time to fusion

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Show Chwan Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 26, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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