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

  • STATUS
    Recruiting
  • End date
    Aug 18, 2023
  • participants needed
    682
  • sponsor
    Hospital del Trabajador de Santiago
Updated on 21 January 2021
cholecalciferol
vitamin d supplementation
vitamin
vitamins
fracture treatment
25 hydroxyvitamin d

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.

Details
Condition Vitamin D Deficiency, Fracture, Fracture Healing, Fracture of tibia, Vitamin Deficiency, Bone Fractures
Treatment Placebo, Vitamin D3.
Clinical Study IdentifierNCT03232216
SponsorHospital del Trabajador de Santiago
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Tibial fracture
ASA physical status classification system I-II
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
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