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Tibial FracturesViDcoNCT03232216

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

A study testing Vitamin D3. in people with Tibial Fractures and Vitamin D Deficiency, run by Hospital del Trabajador de Santiago at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
What is being tested?
Vitamin D3.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
682 participants
Where
1 siteChile
Study dates
21 Nov 2017to 18 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sebastian Drago, MD contact

+56992191310

sdrago@hts.cl

Jose Rojas, MD contact

+56991671221

josemrojasf@gmail.com

Chile1 site, 1 recruiting

  • Hospital del Trabajador de Santiago

    Santiago, Santiago Metropolitan, 8320000

    Sebastián R Drago, MD, +56992191310, sebadrago@gmail.com

    Recruiting

Other trials in Chile

About this study

Official title: 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.

Being tested
Vitamin D3., Placebo
Medical subject headings
Tibial Fractures, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3.Dietary supplement

    Also called Cholecalciferol

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

  • PlaceboDietary supplement

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

Study groups in NCT03232216
Study groupRoleWhat they receive
Vitamin D3 supplementation. Deficiency.ExperimentalVitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.
Receives: Dietary Supplement: Vitamin D3.
Placebo. Deficiency.Placebo comparatorPlacebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.
Receives: Dietary Supplement: Placebo
Vitamin D3 supplementation.InsufficiencyExperimentalVitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Receives: Dietary Supplement: Vitamin D3.
Placebo. Insufficiency.Placebo comparatorPlacebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fracture non union

    Rate of fracture non union in each group

    Measured: 2 years

Secondary outcomes (9)

  1. Prevalence of low vitamin D in adults with tibia fracture

    Using the first measurement of 25 hydroxyvitamin D

    Measured: 10 days

  2. Time of fracture healing

    Time that lasted consolidation, from surgery

    Measured: 2 years

  3. Short Form 36 score (SF-36)

    Health associated quality of life

    Measured: 2 years

  4. EuroQol five dimensions questionnaire (EQ-5D)

    Generic health status measurement

    Measured: 2 years

  5. Knee Range of movement

    Knee flexion and extension in degrees

    Measured: 2 years

  6. Ankle Range of movement

    Ankle flexion and extension in degrees

    Measured: 2 years

  7. Superficial Infections

    Incidence of superficial infections in each group

    Measured: 2 years

  8. Deep infections

    Incidence of superficial infections in each group

    Measured: 2 years

  9. Visual Analogue Scale (VAS)

    Pain measurement using VAS

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2017
  2. Study start21 Nov 2017
  3. Primary completion18 Aug 2021 (estimated)
  4. Study completion18 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
682 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03232216
Sponsor's protocol ID
ViDco
Acronym
ViDco
Status last verified
Nov 2017
First submitted
25 Jul 2017
Last updated
24 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27959647

  • 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.

    PubMed 21646368

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

    PubMed 17634462

  • 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.

    PubMed 26782853

  • 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.

    PubMed 26707619

  • 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.

    PubMed 23351958

  • 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.

    PubMed 28461159

  • 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.

    PubMed 26429406

  • 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.

    PubMed 25694283

  • 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.

    PubMed 27092671

  • 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.

    PubMed 27106800

  • 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.

    PubMed 25715263

  • 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.

    PubMed 27253482

  • 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.

    PubMed 26772945

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3. in people with Tibial Fractures and Vitamin D Deficiency, run by Hospital del Trabajador de Santiago at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sebastian Drago, MD (+56992191310, sdrago@hts.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fracture non union (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232216, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.

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