NCT05023122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 20, 2021

Last Update Submit

August 20, 2021

Conditions

Vitamin DSpinal FusionLumbar Spine Disease

Outcome Measures

Primary Outcomes (1)

  • fusion rate at 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 Outcomes (5)

  • time to fusion

    from postoperative day 1 to postoperative 1 year

  • spine function at postoperative 3 months

    postoperative 3 months

  • spine function at postoperative 6 months

    postoperative 6 months

  • pain at postoperative 3 months

    postoperative 3 months

  • pain at postoperative 6 months

    postoperative 6 months

Study Arms (2)

vitamin D3 + calcium

EXPERIMENTAL

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 D3Dietary Supplement: calcium

calcium only

ACTIVE COMPARATOR

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

Dietary Supplement: calcium

Interventions

vitamin D3DIETARY_SUPPLEMENT

vitamin D3 (cholecalciferol) 800 IU QD

vitamin D3 + calcium
calciumDIETARY_SUPPLEMENT

calcium citrate 600 mg QD

calcium onlyvitamin D3 + calcium

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

Location

Related Publications (1)

  • Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.

    PMID: 36401234DERIVED

MeSH Terms

Conditions

Spinal Diseases

Interventions

CholecalciferolCalcium

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Pei-Yuan Lee, MD, PhD

    Show Chwan Memorial Hospital, Changhua, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary President

Study Record Dates

First Submitted

August 20, 2021

First Posted

August 26, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)