The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
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
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
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