Evidence map›Paper›PMID 36401234›Full record

Trial reportBMC musculoskeletal disorders2022

The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial.

Ming-Hsien Hu, Yu-Kai Tseng, Yu-Hsuan Chung, Nai-Yuan Wu, Chi-Huan Li, Pei-Yuan Lee

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03793530 naunknown statusnot on this map

The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial

TypeinterventionalSponsorPei-Yuan Lee, MDRan2017 to 2020Enrolled40ConditionsBone Marrow, Spinal FusionArmsTransforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration, Transforaminal lumbar interbody fusion with local bone graft
NCT05023122 nacompletednot on this map

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

TypeinterventionalSponsorShow Chwan Memorial HospitalRan2016 to 2018Enrolled34ConditionsVitamin D, Spinal Fusion, Lumbar Spine DiseaseArmsvitamin D3, calcium
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Ming-Hsien Hu *Department of Orthopedics, Show Chwan Memorial Hospital, Changhua, Taiwan.
Yu-Kai Tseng *Department of Orthopedics, Show Chwan Memorial Hospital, Changhua, Taiwan.
Yu-Hsuan ChungDepartment of Orthopedics, Show Chwan Memorial Hospital, Changhua, Taiwan.
Nai-Yuan WuResearch Assistant Center, Show Chwan Memorial Hospital, Changhua, Taiwan.
Chi-Huan LiDepartment of Orthopedics, Chang Bing Show Chwan Memorial Hospital, No. 6 Lugong Rd. Lukang Zhen, Changhua, Changhua County, Taiwan. kei.mail@me.com.
Pei-Yuan LeeDepartment of Orthopedics, Show Chwan Memorial Hospital, Changhua, Taiwan.
Chang Bing Show Chwan Memorial Hospital · TWNational Chung Hsing University · TWDayeh University · TW

Funding

Show Chwan Memorial Hospital, Changhua, Taiwan RD105014Show Chwan Memorial Hospital, Changhua, Taiwan RD106047
6 · The paper itself

Abstract

backgroundPrevious studies have reported that vitamin D supplement could improve fracture healing, but evidence regarding the role of vitamin D supplements in spinal fusion was limited. Thus, this study aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients undergoing lumbar spinal fusion.

methodsThis randomized, double-blind, parallel-designed, active-control trial included the patients who planned for elective lumbar spinal fusion. Eligible patients were randomly assigned to receive either daily vitamin D3 (cholecalciferol) 800 IU and daily calcium citrate 600 mg (experimental group) or only daily calcium citrate 600 mg (control group). All supplements were given from postoperative day 1 and lasted for 3 months. Primary outcome was postoperative 1-year fusion rate, and secondary outcomes included time to fusion, Oswestry Disability Index (ODI), and visual analogue scale (VAS) for pain.

resultsAmong the included 34 patients (21 in the experimental group and 13 in the control group), baseline 25-hydroxyvitamin D (25[OHVitD) level was 26.7 (10.4) ng/ml. Preoperative prevalence of vitamin D deficiency and insufficiency were 23.5% and 47.1%, respectively. Postoperative 1-year fusion rate was not significantly different between the two groups (95.2% vs. 84.6%, P = 0.544). The experimental group had significantly shorter time to fusion (Kaplan-Meier estimated: 169 days vs. 185 days [interquartile range: 88-182 days vs. 176-324 days], log-rank test: P = 0.028), lower postoperative 6-month ODI (P < 0.001), and lower postoperative 6-month VAS (P < 0.001) than the control group. Time to fusion was significantly and negatively correlated with preoperative, postoperative 3-month, and 6-month 25(OH)VitD levels (all P < 0.01).

conclusionThe patient with vitamin D supplements had shorter time to fusion, better spinal function and less pain after elective spinal fusion. Further research is warranted to identify the patients who can benefit the most from vitamin D supplements and the appropriate dose of vitamin D supplements.

trial registrationClinicalTrials.gov, NCT05023122. Registered 20 August 2021. Retrospectively registered, http://clinicaltrials.gov/ct2/show/NCT03793530 .

Indexed as

Spinal DiseasesSpinal FusionCalcium CitrateCholecalciferolHumansPainVitamin DVitaminsCalcium CitrateCholecalciferolVitamin DVitaminsCholecalciferolsFusionPseudoarthrosisSpinal fusionVitamin D

Identifiers

PMID36401234
PMCPMC9673414
OpenAlexW4309466634

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.