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dc.contributor.authorSprague, S.
dc.contributor.authorBzovsky, S.
dc.contributor.authorConnelly, D.
dc.date.accessioned2019-12-04T15:55:05Z
dc.date.available2019-12-04T15:55:05Z
dc.date.issued2019
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85075586023&doi=10.1186%2fs40814-019-0524-4&partnerID=40&md5=321ed4e64a21d824dc5efc2b46c70e1a
dc.identifier.urihttp://hdl.handle.net/10713/11465
dc.description.abstractBackground: Observational studies have found that 75% of healthy adult fracture patients (ages 18-50) have serum 25-hydroxyvitamin D (25(OH)D) levels < 30 ng/mL. Although lower serum 25(OH)D levels have yet to be correlated to fracture healing complications or poor fracture outcomes, many orthopedic surgeons are routinely prescribing vitamin D supplements to improve fracture healing in healthy non-osteoporotic patients. To address this gap in the literature, we propose a phase II exploratory randomized controlled trial comparing three vitamin D3 dosing regimens for early surrogate treatment response. Methods: We will conduct a 4-arm blinded exploratory phase II trial in 96 adults aged 18-50 years with a closed or low-grade open (Gustilo type I or II) tibial or femoral shaft fracture. Eligible patients will be randomized in equal allocation ratio of 1:1:1:1 to one of the treatment groups: (1) 150,000 IU loading dose vitamin D3 plus daily dose placebo; (2) loading dose placebo plus 4000 IU vitamin D3 per day, (3) loading dose placebo plus 600 IU vitamin D3 per day, or (4) loading dose placebo plus daily dose placebo. The primary outcome is fracture healing, assessed as follows: (1) clinical fracture healing measured using the Function IndeX for Trauma, (2) radiographic fracture healing measured using the Radiographic Union Score for Tibial fractures, and (3) biological fracture healing measured using serum levels of cross-linked C-terminal telopeptides of type I collagen and amino-terminal procollagen propeptides of collagen type I. The main secondary outcome will be assessed by measuring serum 25(OH)D levels. All outcome analyses will be exploratory and adhere to the intention-to-treat principle. Per-protocol sensitivity analyses will also be conducted. Discussion: Study results will be disseminated through a publication in an academic journal and presentations at orthopedic conferences. Study results will inform dose selection for a large definitive randomized controlled trial and provide preliminary clinical data on which dose may improve acute fracture healing outcomes in healthy adult patients (18-50 years) at 3 months. Trial registration: Vita-Shock (A Blinded Exploratory Randomized Controlled Trial to Determine Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing) was registered at ClinicalTrials.gov (identifier NCT02786498) prior to enrollment of participants. Copyright 2019 The Author(s).en_US
dc.description.urihttps://doi.org/10.1186/s40814-019-0524-4en_US
dc.language.isoen_USen_US
dc.publisherBioMed Central Ltd.en_US
dc.relation.ispartofPilot and Feasibility Studies
dc.subjectClinical protocolsen_US
dc.subjectFemoral shaft fracturesen_US
dc.subjectFracture fixationen_US
dc.subjectRandomized controlled trialen_US
dc.subjectTibial shaft fracturesen_US
dc.subjectVitamin Den_US
dc.titleStudy protocol: Design and rationale for an exploratory phase II randomized controlled trial to determine optimal vitamin D3 supplementation strategies for acute fracture healingen_US
dc.typeArticleen_US
dc.identifier.doi10.1186/s40814-019-0524-4


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