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Table 1 Schedule of events

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

Assessment

Visit 1: screening and baseline

Visit 2: 6 weeks

Visit 3: 3 months

Visit 4: 6 months

Visit 5: 9 months

Visit 6: 12 months

Screening

     

Serum calcium analysis

*

   

Informed consent

     

Randomization

     

Collection of baseline data (demographic, serum metabolic panel, fracture, and surgical data)

     

Nutritional/placebo supplementation**

   

Assessment of clinical fracture healing (FIX-IT)

 

X-rays of tibia or femur

Assessment of radiographic fracture healing (RUST)

 

Serum bone marker analysis (CTX and PINP)

   

Assessment of adherence to supplementation

 

   

Laboratory serum 25(OH)D analysis

   

Assessment for adverse events

 

Serum PTH level analysis

   

Assessment of fracture healing complications

 

  1. *To be assessed as eligibility criteria
  2. **Must occur within 1 week of fracture