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

NCT ID: NCT05023122

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin D Spinal Fusion Lumbar Spine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

vitamin D3 (cholecalciferol) 800 IU QD

calcium

Intervention Type DIETARY_SUPPLEMENT

calcium citrate 600 mg QD

calcium only

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

Group Type ACTIVE_COMPARATOR

calcium

Intervention Type DIETARY_SUPPLEMENT

calcium citrate 600 mg QD

Interventions

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vitamin D3

vitamin D3 (cholecalciferol) 800 IU QD

Intervention Type DIETARY_SUPPLEMENT

calcium

calcium citrate 600 mg QD

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Show Chwan Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pei-Yuan Lee, MD

Honorary President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei-Yuan Lee, MD, PhD

Role: STUDY_DIRECTOR

Show Chwan Memorial Hospital, Changhua, Taiwan

Locations

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Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 36401234 (View on PubMed)

Other Identifiers

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RD105014

Identifier Type: -

Identifier Source: org_study_id

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