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

NCT05023122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-08-26

No results posted yet for this study

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.

Conditions

  • Vitamin D
  • Spinal Fusion
  • Lumbar Spine Disease

Interventions

DIETARY_SUPPLEMENT

vitamin D3

vitamin D3 (cholecalciferol) 800 IU QD

DIETARY_SUPPLEMENT

calcium

calcium citrate 600 mg QD

Sponsors & Collaborators

  • Show Chwan Memorial Hospital

    lead OTHER

Principal Investigators

  • Pei-Yuan Lee, MD, PhD · Show Chwan Memorial Hospital, Changhua, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023122 on ClinicalTrials.gov