Study protocol: design and rationale for an exploratory phase II randomized controlled trial to determine optimal vitamin D₃ supplementation strategies for acute fracture healing.

ABSTRACT:

Background

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 femor

SUBMITTER: Sprague S 

PROVIDER: S-EPMC6873563 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature