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Table 3 Secondary outcomes analysis

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

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.

  1. *Using a phase II screening trial approach, comparisons are non-definitive and an increased alpha level has been adopted