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

Not Applicable

• Conditions: Vitamin D3; Fracture Healing; Deficiency of Vitamin K2
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D supplementation; Dietary Supplement: Vitamin D and K2 supplementation

• Registration Number: NCT03871322
• Lead Sponsor: Medical University of Bialystok

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

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Study Start: 2019-07-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2022-12-24
• Study Completion: 2023-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo - time to fracture healing
Vitamin D group	Vitamin D supplementation	vitamin D supplementation - time to fracture healing
Vitamin D and K2 group	Vitamin D and K2 supplementation	Vitamin D and K 2 supplementation - time of fracture healing

Primary Outcome Measures

Name	Time	Method
time to bone union	3 months	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

Name	Time	Method
Vitamin D concentration changes	3 months	changes in vitamin D serum concentration
Changes in bone markers concentration	3 months	Changes in bone-specific alkaline phosphatase (BALP), N-terminal telopeptide (NTX)
Vitamin K2 concentration changes	3 months	changes in vitamin K2 serum concentration

Trial Locations

Locations (1)

Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok; 🇵🇱 Bialystok, Poland