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

August 20, 2021 updated by: Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Changhua
      • Changhua City, Changhua, Taiwan, 500
        • Show Chwan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from postoperative day 1 to postoperative 1 year
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.
postoperative 3 months
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.
postoperative 6 months
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).
postoperative 3 months
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).
postoperative 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Show Chwan Memorial Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (ACTUAL)

August 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD105014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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