Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
NCT ID: NCT03232216
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
682 participants
INTERVENTIONAL
2017-11-21
2023-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vitamin D3 supplementation. Deficiency.
Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.
Vitamin D3.
Vitamin D3 50.000 UI in each packet of powder for oral solution.
Placebo. Deficiency.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.
Placebo
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Vitamin D3 supplementation.Insufficiency
Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Vitamin D3.
Vitamin D3 50.000 UI in each packet of powder for oral solution.
Placebo. Insufficiency.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Placebo
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Interventions
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Vitamin D3.
Vitamin D3 50.000 UI in each packet of powder for oral solution.
Placebo
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA physical status classification system I-II.
* 25 hydroxyvitamin D below 30ng/ml)
* Fracture treatment with reamed intramedullary nail
Exclusion Criteria
* 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
18 Years
59 Years
ALL
Yes
Sponsors
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Hospital del Trabajador de Santiago
OTHER
Responsible Party
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Sebastián Drago Pérez
Orthopedic Surgeon
Principal Investigators
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Sebastian Drago
Role: PRINCIPAL_INVESTIGATOR
Hospital del Trabajador de Santiago
Locations
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Hospital del Trabajador de Santiago
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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Sebastián R Drago, MD
Role: primary
References
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Manson JE, Brannon PM, Rosen CJ, Taylor CL. Vitamin D Deficiency - Is There Really a Pandemic? N Engl J Med. 2016 Nov 10;375(19):1817-1820. doi: 10.1056/NEJMp1608005. No abstract available.
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Schwartz JB, Kane L, Bikle D. Response of Vitamin D Concentration to Vitamin D3 Administration in Older Adults without Sun Exposure: A Randomized Double-Blind Trial. J Am Geriatr Soc. 2016 Jan;64(1):65-72. doi: 10.1111/jgs.13774.
Talib HJ, Ponnapakkam T, Gensure R, Cohen HW, Coupey SM. Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial. J Pediatr. 2016 Mar;170:266-72.e1. doi: 10.1016/j.jpeds.2015.11.025. Epub 2015 Dec 18.
Vieth, R: The pharmacology of vitamin D. Vitam D 2011;1041-1066. doi:10.1016/B978-0-12-381978-9.10057-5
Antonova E, Le TK, Burge R, Mershon J. Tibia shaft fractures: costly burden of nonunions. BMC Musculoskelet Disord. 2013 Jan 26;14:42. doi: 10.1186/1471-2474-14-42.
Khaw KT, Stewart AW, Waayer D, Lawes CMM, Toop L, Camargo CA Jr, Scragg R. Effect of monthly high-dose vitamin D supplementation on falls and non-vertebral fractures: secondary and post-hoc outcomes from the randomised, double-blind, placebo-controlled ViDA trial. Lancet Diabetes Endocrinol. 2017 Jun;5(6):438-447. doi: 10.1016/S2213-8587(17)30103-1. Epub 2017 Apr 28.
Sprague S, Petrisor B, Scott T, Devji T, Phillips M, Spurr H, Bhandari M, Slobogean GP. What Is the Role of Vitamin D Supplementation in Acute Fracture Patients? A Systematic Review and Meta-Analysis of the Prevalence of Hypovitaminosis D and Supplementation Efficacy. J Orthop Trauma. 2016 Feb;30(2):53-63. doi: 10.1097/BOT.0000000000000455.
Carrasco G M, Dominguez De L A, Martinez F G, Ihle S S, Rojas A V, Foradori C A, Marin L PP. [Vitamin D levels in older healthy Chilean adults and their association with functional performance]. Rev Med Chil. 2014 Nov;142(11):1385-91. doi: 10.4067/S0034-98872014001100004. Spanish.
Schweitzer D, Amenabar PP, Botello E, Lopez M, Saavedra Y, Klaber I. [Vitamin D levels among Chilean older subjects with low energy hip fracture]. Rev Med Chil. 2016 Feb;144(2):175-80. doi: 10.4067/S0034-98872016000200005. Spanish.
Souberbielle JC, Massart C, Brailly-Tabard S, Cavalier E, Chanson P. Prevalence and determinants of vitamin D deficiency in healthy French adults: the VARIETE study. Endocrine. 2016 Aug;53(2):543-50. doi: 10.1007/s12020-016-0960-3. Epub 2016 Apr 22.
Yu S, Fang H, Han J, Cheng X, Xia L, Li S, Liu M, Tao Z, Wang L, Hou L, Qin X, Li P, Zhang R, Su W, Qiu L. The high prevalence of hypovitaminosis D in China: a multicenter vitamin D status survey. Medicine (Baltimore). 2015 Feb;94(8):e585. doi: 10.1097/MD.0000000000000585.
Bodendorfer BM, Cook JL, Robertson DS, Della Rocca GJ, Volgas DA, Stannard JP, Crist BD. Do 25-Hydroxyvitamin D Levels Correlate With Fracture Complications? J Orthop Trauma. 2016 Sep;30(9):e312-7. doi: 10.1097/BOT.0000000000000639.
Bell A, Templeman D, Weinlein JC. Nonunion of the Femur and Tibia: An Update. Orthop Clin North Am. 2016 Apr;47(2):365-75. doi: 10.1016/j.ocl.2015.09.010.
Duan X, Al-Qwbani M, Zeng Y, Zhang W, Xiang Z. Intramedullary nailing for tibial shaft fractures in adults. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008241. doi: 10.1002/14651858.CD008241.pub2.
Other Identifiers
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ViDco
Identifier Type: -
Identifier Source: org_study_id