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

Vitamin D Deficiency Clinical Trial

— ViDco  

Official title:

Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232216
• Other study ID #: ViDco
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2017
• Last updated: November 21, 2017
• Start date: November 21, 2017
• Est. completion date: August 18, 2023

Study information

• Verified date: November 2017
• Source: Hospital del Trabajador de Santiago
• Contact: Sebastian Drago, MD
• Phone: +56992191310
• Email: sdrago[@]hts.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 682
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture Healing
• Fractures, Bone
• Tibial Fractures
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Chile	Hospital del Trabajador de Santiago	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Trabajador de Santiago

Country where clinical trial is conducted

Chile, 

References & Publications (16)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Carrasco G M, Domínguez De L A, Martínez F G, Ihle S S, Rojas Á V, Foradori C A, Marín 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/S0034-9 — View Citation

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:CD008241. doi: 10.1002/14651858.CD008241.pub2. Review. — View Citation

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. Erratum in: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schweitzer D, Amenábar PP, Botello E, López 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. — View Citation

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. — View Citation

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 Supplementat — View Citation

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. — View Citation

Vieth, R: The pharmacology of vitamin D. Vitam D 2011;1041-1066. doi:10.1016/B978-0-12-381978-9.10057-5

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 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture non union	Rate of fracture non union in each group	2 years
Secondary	Prevalence of low vitamin D in adults with tibia fracture	Using the first measurement of 25 hydroxyvitamin D	10 days
Secondary	Time of fracture healing	Time that lasted consolidation, from surgery	2 years
Secondary	Short Form 36 score (SF-36)	Health associated quality of life	2 years
Secondary	EuroQol five dimensions questionnaire (EQ-5D)	Generic health status measurement	2 years
Secondary	Knee Range of movement	Knee flexion and extension in degrees	2 years
Secondary	Ankle Range of movement	Ankle flexion and extension in degrees	2 years
Secondary	Superficial Infections	Incidence of superficial infections in each group	2 years
Secondary	Deep infections	Incidence of superficial infections in each group	2 years
Secondary	Visual Analogue Scale (VAS)	Pain measurement using VAS	2 years