Status:
UNKNOWN
The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
Lead Sponsor:
Medical University of Bialystok
Collaborating Sponsors:
Lomza State University of Applied Sciences
International Science & Health Foundation
Conditions:
Fracture Healing
Vitamin D3
Eligibility:
All Genders
3-18 years
Phase:
NA
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 l...
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 ...
Eligibility Criteria
Inclusion
- Age \< 18 years
- Presence of low-energy fracture
- Vitamin D serum level \<30ng/ml
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03871322
Start Date
July 1 2019
End Date
January 20 2023
Last Update
March 10 2021
Active Locations (1)
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1
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Bialystok, Poland, 15-274