Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial

Conditions
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Tibial Fractures, Vitamin D Deficiency, Fracture Healing

Intervention / Treatment
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* Dietary Supplement: Vitamin D3.
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 supplementation. Deficiency.<br>Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks. | Dietary Supplement: Vitamin D3.<br>* Vitamin D3 50.000 UI in each packet of powder for oral solution.<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo. Deficiency.<br>Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks. | Dietary Supplement: Placebo<br>* Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.<br>|
| Experimental: Vitamin D3 supplementation.Insufficiency<br>Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks. | Dietary Supplement: Vitamin D3.<br>* Vitamin D3 50.000 UI in each packet of powder for oral solution.<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo. Insufficiency.<br>Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks. | Dietary Supplement: Placebo<br>* Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture non union | Rate of fracture non union in each group | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of low vitamin D in adults with tibia fracture | Using the first measurement of 25 hydroxyvitamin D | 10 days | 
| Time of fracture healing | Time that lasted consolidation, from surgery | 2 years | 
| Short Form 36 score (SF-36) | Health associated quality of life | 2 years | 
| EuroQol five dimensions questionnaire (EQ-5D) | Generic health status measurement | 2 years | 
| Knee Range of movement | Knee flexion and extension in degrees | 2 years | 
| Ankle Range of movement | Ankle flexion and extension in degrees | 2 years | 
| Superficial Infections | Incidence of superficial infections in each group | 2 years | 
| Deep infections | Incidence of superficial infections in each group | 2 years | 
| Visual Analogue Scale (VAS) | Pain measurement using VAS | 2 years |