Back to resultsVitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate? (ViDco)
Primary Purpose
Tibial Fractures, Vitamin D Deficiency, Fracture Healing
Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Vitamin D3.
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Tibial Fractures
Eligibility 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
Sites / Locations
- Hospital del Trabajador de SantiagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Vitamin D3 supplementation. Deficiency.
Placebo. Deficiency.
Vitamin D3 supplementation.Insufficiency
Placebo. Insufficiency.
Arm Description
Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.
Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Outcomes
Primary Outcome Measures
Fracture non union
Rate of fracture non union in each group
Secondary Outcome Measures
Prevalence of low vitamin D in adults with tibia fracture
Using the first measurement of 25 hydroxyvitamin D
Time of fracture healing
Time that lasted consolidation, from surgery
Short Form 36 score (SF-36)
Health associated quality of life
EuroQol five dimensions questionnaire (EQ-5D)
Generic health status measurement
Knee Range of movement
Knee flexion and extension in degrees
Ankle Range of movement
Ankle flexion and extension in degrees
Superficial Infections
Incidence of superficial infections in each group
Deep infections
Incidence of superficial infections in each group
Visual Analogue Scale (VAS)
Pain measurement using VAS
Full Information
NCT ID
NCT03232216
First Posted
July 25, 2017
Last Updated
November 21, 2017
Sponsor
Hospital del Trabajador de Santiago
1. Study Identification
Unique Protocol Identification Number
NCT03232216
Brief Title
Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
Acronym
ViDco
Official Title
Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
August 18, 2021 (Anticipated)
Study Completion Date
August 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Trabajador de Santiago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Vitamin D Deficiency, Fracture Healing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
682 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 supplementation. Deficiency.
Arm Type
Experimental
Arm Description
Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.
Arm Title
Placebo. Deficiency.
Arm Type
Placebo Comparator
Arm Description
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.
Arm Title
Vitamin D3 supplementation.Insufficiency
Arm Type
Experimental
Arm Description
Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Arm Title
Placebo. Insufficiency.
Arm Type
Placebo Comparator
Arm Description
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3.
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Vitamin D3 50.000 UI in each packet of powder for oral solution.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
Primary Outcome Measure Information:
Title
Fracture non union
Description
Rate of fracture non union in each group
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Prevalence of low vitamin D in adults with tibia fracture
Description
Using the first measurement of 25 hydroxyvitamin D
Time Frame
10 days
Title
Time of fracture healing
Description
Time that lasted consolidation, from surgery
Time Frame
2 years
Title
Short Form 36 score (SF-36)
Description
Health associated quality of life
Time Frame
2 years
Title
EuroQol five dimensions questionnaire (EQ-5D)
Description
Generic health status measurement
Time Frame
2 years
Title
Knee Range of movement
Description
Knee flexion and extension in degrees
Time Frame
2 years
Title
Ankle Range of movement
Description
Ankle flexion and extension in degrees
Time Frame
2 years
Title
Superficial Infections
Description
Incidence of superficial infections in each group
Time Frame
2 years
Title
Deep infections
Description
Incidence of superficial infections in each group
Time Frame
2 years
Title
Visual Analogue Scale (VAS)
Description
Pain measurement using VAS
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Drago, MD
Phone
+56992191310
Email
sdrago@hts.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Rojas, MD
Phone
+56991671221
Email
josemrojasf@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Drago
Organizational Affiliation
Hospital del Trabajador de Santiago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Trabajador de Santiago
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastián R Drago, MD
Phone
+56992191310
Email
sebadrago@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27959647
Citation
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Citation
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Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
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