Status:
UNKNOWN
Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
Lead Sponsor:
Hospital del Trabajador de Santiago
Conditions:
Tibial Fractures
Vitamin D Deficiency
Eligibility:
All Genders
18-59 years
Phase:
NA
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 whil...
Eligibility Criteria
Inclusion
- Tibial fracture
- ASA physical status classification system I-II.
- 25 hydroxyvitamin D below 30ng/ml)
- Fracture treatment with reamed intramedullary nail
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2023
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT03232216
Start Date
November 21 2017
End Date
August 18 2023
Last Update
November 24 2017
Active Locations (1)
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1
Hospital del Trabajador de Santiago
Santiago, Santiago Metropolitan, Chile, 8320000