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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03232216
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sebastián Drago Pérez, Hospital del Trabajador de Santiago

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.

Condition or disease Intervention/treatment Phase
Tibial Fractures Vitamin D Deficiency Fracture Healing Dietary Supplement: Vitamin D3. Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : August 18, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Fracture non union [ Time Frame: 2 years ]
    Rate of fracture non union in each group


Secondary Outcome Measures :
  1. Prevalence of low vitamin D in adults with tibia fracture [ Time Frame: 10 days ]
    Using the first measurement of 25 hydroxyvitamin D

  2. Time of fracture healing [ Time Frame: 2 years ]
    Time that lasted consolidation, from surgery

  3. Short Form 36 score (SF-36) [ Time Frame: 2 years ]
    Health associated quality of life

  4. EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: 2 years ]
    Generic health status measurement

  5. Knee Range of movement [ Time Frame: 2 years ]
    Knee flexion and extension in degrees

  6. Ankle Range of movement [ Time Frame: 2 years ]
    Ankle flexion and extension in degrees

  7. Superficial Infections [ Time Frame: 2 years ]
    Incidence of superficial infections in each group

  8. Deep infections [ Time Frame: 2 years ]
    Incidence of superficial infections in each group

  9. Visual Analogue Scale (VAS) [ Time Frame: 2 years ]
    Pain measurement using VAS



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232216


Contacts
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Contact: Sebastian Drago, MD +56992191310 sdrago@hts.cl
Contact: Jose Rojas, MD +56991671221 josemrojasf@gmail.com

Locations
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Chile
Hospital del Trabajador de Santiago Recruiting
Santiago, Metropolitana, Chile, 8320000
Contact: Sebastián R Drago, MD    +56992191310    sebadrago@gmail.com   
Sponsors and Collaborators
Hospital del Trabajador de Santiago
Investigators
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Principal Investigator: Sebastian Drago Hospital del Trabajador de Santiago
Publications of Results:

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

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Responsible Party: Sebastián Drago Pérez, Orthopedic Surgeon, Hospital del Trabajador de Santiago
ClinicalTrials.gov Identifier: NCT03232216    
Other Study ID Numbers: ViDco
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Leg Injuries
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents