Clinical trial NCT03232216: Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
Official title: Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tibial Fractures
Vitamin D Deficiency
Fracture Healing
Lead sponsor: Hospital del Trabajador de Santiago
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Tibial fracture
* ASA physical status classification system I-II.
* 25 hydroxyvitamin D below 30ng/ml)
* Fracture treatment with reamed intramedullary nail

Exclusion Criteria:

* Open Fractures Gustillo III B and III C
* Closed Soft tissue injury with Tscherne classification of III
* Acute Compartment Syndrome
* Pathology fractures (That occur in abnormal bone, for example in the presence of tumor, cyst or Paget disease)
* Other Fractures in lower limbs or spine that does not allow full weight bearing of the operated tibia after 4 weeks
* More than 7 days of evolution from fracture occurrence
* Diabetes mellitus with HbA1c more or equal than 7%
* Peripheral vascular disease
* Rickets
* Pre-existing disorders of the metabolism of Vitamin D and/or homeostasis of calcium and phosphorous (ie. Hepatic insufficiency, congenital defects of the vitamin D metabolism, disorders of the parathyroid glands, hypo or hyper calcemia)
* Renal failure with glomerular filtration rate below 60ml/min according to MDRD-4.
* Patients using nephrotoxic medications in high doses, requiring periodical monitoring of glomerular filtration rate
* Patients undergoing with nephrotic syndrome or that suffered it in the past
* Patients that suffered nephrolithiasis or urolithiasis
* Pregnant women
* Patients with allergy to vitamin D or other contraindications for vitamin D3 prescription
* Patients that are taking multivitamin supplements containing vitamin D and will not suspend taking them during the study.
* Patients that are not able to swallow a cup of water

Primary outcomes:
measure: Fracture non union
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of low vitamin D in adults with tibia fracture
timeFrame: 10 days
measure: Time of fracture healing
timeFrame: 2 years
measure: Short Form 36 score (SF-36)
timeFrame: 2 years
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: 2 years
measure: Knee Range of movement
timeFrame: 2 years
measure: Ankle Range of movement
timeFrame: 2 years
measure: Superficial Infections
timeFrame: 2 years
measure: Deep infections
timeFrame: 2 years
measure: Visual Analogue Scale (VAS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital del Trabajador de Santiago
state: Metropolitana
Study officials:
affiliation: Hospital del Trabajador de Santiago
name: Sebastian Drago
role: PRINCIPAL_INVESTIGATOR
References:
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