This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3 supplementation while the other will receive placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
682
Vitamin D3 50.000 UI in each packet of powder for oral solution.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Hospital del Trabajador de Santiago
Santiago, Santiago Metropolitan, Chile
RECRUITINGFracture non union
Rate of fracture non union in each group
Time frame: 2 years
Prevalence of low vitamin D in adults with tibia fracture
Using the first measurement of 25 hydroxyvitamin D
Time frame: 10 days
Time of fracture healing
Time that lasted consolidation, from surgery
Time frame: 2 years
Short Form 36 score (SF-36)
Health associated quality of life
Time frame: 2 years
EuroQol five dimensions questionnaire (EQ-5D)
Generic health status measurement
Time frame: 2 years
Knee Range of movement
Knee flexion and extension in degrees
Time frame: 2 years
Ankle Range of movement
Ankle flexion and extension in degrees
Time frame: 2 years
Superficial Infections
Incidence of superficial infections in each group
Time frame: 2 years
Deep infections
Incidence of superficial infections in each group
Time frame: 2 years
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Visual Analogue Scale (VAS)
Pain measurement using VAS
Time frame: 2 years