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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 supplementation. Deficiency. | Experimental | Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks. |
|
| Placebo. Deficiency. | Placebo Comparator | 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 | Experimental | Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks. |
|
| Placebo. Insufficiency. | Placebo Comparator | Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3. | Dietary Supplement | Vitamin D3 50.000 UI in each packet of powder for oral solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fracture non union | Rate of fracture non union in each group | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Drago, MD | Contact | +56992191310 | sdrago@hts.cl | |
| Jose Rojas, MD | Contact | +56991671221 | josemrojasf@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Drago | Hospital del Trabajador de Santiago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Trabajador de Santiago | Recruiting | Santiago | Santiago Metropolitan | 8320000 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27959647 | Background | 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. | |
| 21646368 | Background | 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. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo | Dietary Supplement | Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. |
|
| 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 |
| 17634462 | Background | Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. |
| 26782853 | Background | 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. |
| 26707619 | Background | 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. |
| Background | Vieth, R: The pharmacology of vitamin D. Vitam D 2011;1041-1066. doi:10.1016/B978-0-12-381978-9.10057-5 |
| 23351958 | Background | 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. |
| 28461159 | Background | 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. |
| 26429406 | Result | 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. |
| 25694283 | Result | 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. |
| 27092671 | Result | 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. |
| 27106800 | Result | 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. |
| 25715263 | Result | 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. |
| 27253482 | Result | 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. |
| 26772945 | Result | 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. |
| 22258982 | Result | 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. |
| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |