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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Tibial Fractures; Fracture Healing
• Intervention / Treatment: Dietary supplement: Vitamin D3.; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 682
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Drago, MD; Phone Number: +56992191310; Email: sdrago@hts.cl
• Study Contact Backup: Name: Jose Rojas, MD; Phone Number: +56991671221; Email: josemrojasf@gmail.com

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8320000
      • Recruiting
      • Hospital del Trabajador de Santiago
      • Contact: Sebastián R Drago, MD; Phone Number: +56992191310; Email: sebadrago@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D3 supplementation. Deficiency.; Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.	Dietary supplement: Vitamin D3.; Vitamin D3 50.000 UI in each packet of powder for oral solution.; Other Names: Cholecalciferol
Placebo Comparator: Placebo. Deficiency.; Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.	Dietary supplement: Placebo; Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Experimental: Vitamin D3 supplementation.Insufficiency; Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.	Dietary supplement: Vitamin D3.; Vitamin D3 50.000 UI in each packet of powder for oral solution.; Other Names: Cholecalciferol
Placebo Comparator: Placebo. Insufficiency.; Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.	Dietary supplement: Placebo; Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture non union	Rate of fracture non union in each group	2 years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital del Trabajador de Santiago
• Investigators: Principal Investigator: Sebastian Drago, Hospital del Trabajador de Santiago

Publications and helpful links

General Publications

• 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.
• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
• 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.
• 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.
• 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
• 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. Erratum In: Medicine (Baltimore). 2015 Mar;94(11):1.
• 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:CD008241. doi: 10.1002/14651858.CD008241.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Anticipated): August 18, 2021
• Study Completion (Anticipated): August 18, 2023

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Fractures, Bone; Tibial Fractures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ViDco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No