The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
Primary Purpose
Fracture Healing, Vitamin D3, Deficiency of Vitamin K2
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Vitamin D and K2 supplementation
Vitamin D supplementation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Healing focused on measuring vitamin D, vitamin K2, low-energy fractures, fracture healing, children
Eligibility Criteria
Inclusion Criteria:
- Age < 18 years
- Presence of low-energy fracture
- Vitamin D serum level <30ng/ml
Exclusion Criteria:
- Age > 18 years
- Lack of low-energy bone fracture
- Oral anticoagulants treatments, which interfere with vitamin K cycle
- Current supplementation with vitamin vitamins K2 or vitamin D3
- Osteogenesis imperfecta and other bone diseases
- Vitamin D concentration > 30ng/ml
Sites / Locations
- Department of Pediatric Orthopedics and Traumatology Medical University of BialystokRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Vitamin D group
Vitamin D and K2 group
Placebo group
Arm Description
vitamin D supplementation - time to fracture healing
Vitamin D and K 2 supplementation - time of fracture healing
Placebo - time to fracture healing
Outcomes
Primary Outcome Measures
time to bone union
The bone fracture healing milestones will be based on bone union defined as the absence of pain and the presence of bridging callus in three of the four cortices seen on the AnteroPosteral and lateral radiographs
Secondary Outcome Measures
Vitamin D concentration changes
changes in vitamin D serum concentration
Vitamin K2 concentration changes
changes in vitamin K2 serum concentration
Changes in bone markers concentration
Changes in bone-specific alkaline phosphatase (BALP), N-terminal telopeptide (NTX)
Full Information
NCT ID
NCT03871322
First Posted
March 7, 2019
Last Updated
March 8, 2021
Sponsor
Medical University of Bialystok
Collaborators
Lomza State University of Applied Sciences, International Science & Health Foundation, American Medical Holdings Inc
1. Study Identification
Unique Protocol Identification Number
NCT03871322
Brief Title
The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
Official Title
Rationale and Design of the Vitamin K2 and Vitamin D3 Intervention Trial in Children and Adolescents With the Low-energy Bone Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 24, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
Collaborators
Lomza State University of Applied Sciences, International Science & Health Foundation, American Medical Holdings Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC), investigating the effect of vitamin K2 (menaquinone-7) and vitamin D3 on the healing process of low-energy bone fractures in children and adolescents
Detailed Description
At the admission of patients to the orthopedic outpatient clinic, presence of low- energy fractures will be established based on the anamnesis, physical examination and radiological evaluation. Tests to obtain the baseline blood levels of vitamin D3 will be performed, and only children with vitamin D3 levels lower than 30ng/ml in the blood will be included in the study. The selected population will then be randomly assigned by an independent investigator to the three study groups, receiving daily for three months identical- looking soft gel capsules (1 capsule/patient/day) containing supplements of vitamin D3 2,000 IU, 90 mcg of vitamin K2 as menaquinone-7 combined with 2,000 IU D3, and olive oil-containing placebo capsules respectively. During the 3-month follow-up visits to the outpatient orthopedic clinic, the pediatric orthopedist will examine the patient, evaluate the X-ray, and determine the progress in bone union and the range of joint motion. The patients will visit the clinic on weeks 1,2,4,6,8, and 12. The compliance taking the supplements will be assessed by registering a pill count returned by a patient during the scheduled visit. The blood samples will be collected upon admission to the study, day 0, and after the 3-month regimen. The blood samples will be collected for evaluation of bone turnover markers and the status of vitamin K and vitamin D3. The primary evaluation endpoints will include: the dynamics of fracture healing, changes in levels of osteocalcin, and vitamin K and vitamin D3 levels against the placebo group. The bone fracture healing milestones will be based on bone union defined as the absence of pain and the presence of bridging callus in three of the four cortices seen on the front rear projection and lateral radiographic views of the bone. Delayed union is defined as incomplete consolidation at 90 Days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Healing, Vitamin D3, Deficiency of Vitamin K2
Keywords
vitamin D, vitamin K2, low-energy fractures, fracture healing, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC),
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blind, placebo, same looking capsules
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D group
Arm Type
Active Comparator
Arm Description
vitamin D supplementation - time to fracture healing
Arm Title
Vitamin D and K2 group
Arm Type
Active Comparator
Arm Description
Vitamin D and K 2 supplementation - time of fracture healing
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo - time to fracture healing
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and K2 supplementation
Intervention Description
if supplementation of vitamin D and K2 changes the time to fracture healing
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplementation
Intervention Description
if supplementation of vitamin D alone changes the time to fracture healing
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo control group
Primary Outcome Measure Information:
Title
time to bone union
Description
The bone fracture healing milestones will be based on bone union defined as the absence of pain and the presence of bridging callus in three of the four cortices seen on the AnteroPosteral and lateral radiographs
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vitamin D concentration changes
Description
changes in vitamin D serum concentration
Time Frame
3 months
Title
Vitamin K2 concentration changes
Description
changes in vitamin K2 serum concentration
Time Frame
3 months
Title
Changes in bone markers concentration
Description
Changes in bone-specific alkaline phosphatase (BALP), N-terminal telopeptide (NTX)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age < 18 years
Presence of low-energy fracture
Vitamin D serum level <30ng/ml
Exclusion Criteria:
Age > 18 years
Lack of low-energy bone fracture
Oral anticoagulants treatments, which interfere with vitamin K cycle
Current supplementation with vitamin vitamins K2 or vitamin D3
Osteogenesis imperfecta and other bone diseases
Vitamin D concentration > 30ng/ml
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Karpiński, MD
Phone
692224714
Ext
48
Email
gufkarp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Popko, MD, PhD
Organizational Affiliation
Faculty of Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michał Karpinski, MD
Organizational Affiliation
Department of Pediatric Orthopedics and Traumatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Guszczyn, MD, PhD
Organizational Affiliation
Department of Pediatric Orthopedics and Traumatology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sylwia Chojnowska, PhD
Organizational Affiliation
Faculty of Health Sciences Lomza
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katarzyna Maresz, PhD
Organizational Affiliation
International Science &Health Foundation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vladimir Badmaev
Organizational Affiliation
American Medical Holdings Inc
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Karpinski, MD
Phone
692224714
Ext
+48
Email
gufkarp@gmail.com
First Name & Middle Initial & Last Name & Degree
Janusz Popko, MD, PhD
Phone
857450895
Ext
+48
Email
jpopko@umb.edu.pl
First Name & Middle Initial & Last Name & Degree
Michal Karpinski, MD
First Name & Middle Initial & Last Name & Degree
Janusz Popko, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vladimir Badmaev, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tomasz Guszczyn, MD, PhD
First Name & Middle Initial & Last Name & Degree
Katarzyna Maresz, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
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