Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
Not Applicable
- Conditions
- Tibial FracturesVitamin D DeficiencyFracture Healing
- Interventions
- Dietary Supplement: Vitamin D3.Dietary Supplement: Placebo
- Registration Number
- NCT03232216
- Lead Sponsor
- Hospital del Trabajador de Santiago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 682
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D3 supplementation. Deficiency. Vitamin D3. Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks. Placebo. Insufficiency. Placebo Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks. Placebo. Deficiency. Placebo Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks. Vitamin D3 supplementation.Insufficiency Vitamin D3. Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
- Primary Outcome Measures
Name Time Method Fracture non union 2 years Rate of fracture non union in each group
- Secondary Outcome Measures
Name Time Method Short Form 36 score (SF-36) 2 years Health associated quality of life
Deep infections 2 years Incidence of superficial infections in each group
EuroQol five dimensions questionnaire (EQ-5D) 2 years Generic health status measurement
Knee Range of movement 2 years Knee flexion and extension in degrees
Ankle Range of movement 2 years Ankle flexion and extension in degrees
Superficial Infections 2 years Incidence of superficial infections in each group
Visual Analogue Scale (VAS) 2 years Pain measurement using VAS
Prevalence of low vitamin D in adults with tibia fracture 10 days Using the first measurement of 25 hydroxyvitamin D
Time of fracture healing 2 years Time that lasted consolidation, from surgery
Trial Locations
- Locations (1)
Hospital del Trabajador de Santiago
🇨🇱Santiago, Metropolitana, Chile