Objective | Hypothesis | Outcome | Method of analysis |
---|---|---|---|
Main secondary outcome | |||
 To determine if 25(OH)D serum levels are associated with fracture healing at 3 months | There will be an association between fracture healing and: | 1. FIX-IT (Clinical) | Associations will be quantified using univariate analysis (alpha = 0.20).*. |
2. RUST (Radiographic) | |||
1) Patients’ enrolment serum 25(OH)D | |||
3. PINP (Biologic) | |||
4. CTX (Biologic) | |||
2) Their change in 25(OH)D from enrolment to 3 months | |||
3) Their 25(OH)D level at 3 months | |||
Other secondary outcomes | |||
 Supplementation adherence | Daily vitamin D3 adherence will be < 80% and loading dose vitamin D3 adherence will be > 95%. | Self-report | Summary statistics of means and confidence interval. |
Count of pills | |||
 Participant safety | Adverse events will be rare across all 4 treatment groups. | Adverse event | Summary statistics of proportions. |
Re-operations for a composite of fracture healing complications will follow the same 3 hypotheses as fracture healing. | Re-operations for a composite of fracture healing complications | Summary statistics of proportions. | |
Levels of serum calcium will be similar across the 4 treatment groups. Levels of serum calcium will be within normal reference ranges. | Serum calcium | Summary statistics of means and confidence interval. | |
Levels of serum PTH will be similar across the 4 treatment groups. Levels of serum PTH will be within normal reference ranges. | Serum PTH | Summary statistics of means and confidence interval. | |
 Protocol adherence | Protocol adherence will be acceptable. | Complete follow-up assessments including x-rays and bloodwork | Summary statistics of proportions. |