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

Fracture Healing Clinical Trial

Official title:

Rationale and Design of the Vitamin K2 and Vitamin D3 Intervention Trial in Children and Adolescents With the Low-energy Bone Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03871322
• Other study ID #: MUBialystok1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 20, 2023

Study information

• Verified date: March 2021
• Source: Medical University of Bialystok
• Contact: Michal Karpinski, MD
• Phone: 692224714
• Email: gufkarp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 20, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficiency of Vitamin K2
• Fracture Healing
• Fractures, Bone
• Vitamin D3
• Vitamin K Deficiency

Intervention

Dietary Supplement:
• Vitamin D and K2 supplementation
if supplementation of vitamin D and K2 changes the time to fracture healing
• Vitamin D supplementation
if supplementation of vitamin D alone changes the time to fracture healing
• Placebo
Placebo control group

Locations

Country	Name	City	State
Poland	Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok	Bialystok

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of Bialystok	American Medical Holdings Inc, International Science & Health Foundation, Lomza State University of Applied Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	Vitamin D concentration changes	changes in vitamin D serum concentration	3 months
Secondary	Vitamin K2 concentration changes	changes in vitamin K2 serum concentration	3 months
Secondary	Changes in bone markers concentration	Changes in bone-specific alkaline phosphatase (BALP), N-terminal telopeptide (NTX)	3 months