NCT03232216

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
682

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

July 25, 2017

Last Update Submit

November 21, 2017

Conditions

Tibial FracturesVitamin D DeficiencyFracture Healing

Outcome Measures

Primary Outcomes (1)

  • Fracture non union

    Rate of fracture non union in each group

    2 years

Secondary Outcomes (9)

  • Prevalence of low vitamin D in adults with tibia fracture

    10 days

  • Time of fracture healing

    2 years

  • Short Form 36 score (SF-36)

    2 years

  • EuroQol five dimensions questionnaire (EQ-5D)

    2 years

  • Knee Range of movement

    2 years

  • +4 more secondary outcomes

Study Arms (4)

Vitamin D3 supplementation. Deficiency.

EXPERIMENTAL

Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.

Dietary Supplement: Vitamin D3.

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.

Dietary Supplement: Placebo

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.

Dietary Supplement: Vitamin D3.

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.

Dietary Supplement: Placebo

Interventions

Vitamin D3.DIETARY_SUPPLEMENT

Vitamin D3 50.000 UI in each packet of powder for oral solution.

Also known as: Cholecalciferol
Vitamin D3 supplementation. Deficiency.Vitamin D3 supplementation.Insufficiency
PlaceboDIETARY_SUPPLEMENT

Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.

Placebo. Deficiency.Placebo. Insufficiency.

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Tibial fracture
  • ASA physical status classification system I-II.
  • hydroxyvitamin D below 30ng/ml)
  • Fracture treatment with reamed intramedullary nail

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Trabajador de Santiago

Santiago, Santiago Metropolitan, 8320000, Chile

RECRUITING

Related Publications (16)

  • 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.

    PMID: 27959647BACKGROUND

  • 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.

    PMID: 21646368BACKGROUND

  • Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

    PMID: 17634462BACKGROUND

  • 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.

    PMID: 26782853BACKGROUND

  • 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.

    PMID: 26707619BACKGROUND

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

    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.

    PMID: 23351958BACKGROUND

  • 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.

    PMID: 28461159BACKGROUND

  • 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.

    PMID: 26429406RESULT

  • 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.

    PMID: 25694283RESULT

  • 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.

    PMID: 27092671RESULT

  • 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.

    PMID: 27106800RESULT

  • 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.

    PMID: 25715263RESULT

  • 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.

    PMID: 27253482RESULT

  • 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.

    PMID: 26772945RESULT

  • 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.

    PMID: 22258982RESULT

MeSH Terms

Conditions

Tibial FracturesVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sebastian Drago

    Hospital del Trabajador de Santiago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Drago, MD

CONTACT

+56992191310sdrago@hts.cl

Jose Rojas, MD

CONTACT

+56991671221josemrojasf@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

November 21, 2017

Primary Completion

August 18, 2021

Study Completion

August 18, 2023

Last Updated

November 24, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)