Clinical trial NCT03871322: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Healing
Vitamin D3
Deficiency of Vitamin K2
Keywords: vitamin D
vitamin K2
low-energy fractures
fracture healing
children
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: Lomza State University of Applied Sciences
name: International Science & Health Foundation
name: American Medical Holdings Inc
First posted: 2019-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC),
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: time to bone union
timeFrame: 3 months
Secondary outcomes:
measure: Vitamin D concentration changes
timeFrame: 3 months
measure: Vitamin K2 concentration changes
timeFrame: 3 months
measure: Changes in bone markers concentration
timeFrame: 3 months
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Study officials:
affiliation: Faculty of Health Sciences
name: Janusz Popko, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Pediatric Orthopedics and Traumatology
name: Michał Karpinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatric Orthopedics and Traumatology
name: Tomasz Guszczyn, MD, PhD
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences Lomza
name: Sylwia Chojnowska, PhD
role: STUDY_CHAIR
affiliation: International Science &amp;Health Foundation
name: Katarzyna Maresz, PhD
role: STUDY_CHAIR
affiliation: American Medical Holdings Inc
name: Vladimir Badmaev
role: STUDY_DIRECTOR
References: