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

NCT03871322 | Unknown

• 1 other identifier: MUBialystok1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Fracture Healing; Vitamin D3; Deficiency of Vitamin K2

Keywords

vitamin D; vitamin K2; low-energy fractures; fracture healing; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vitamin D concentration changes

  3 months

• Vitamin K2 concentration changes

  3 months

• Changes in bone markers concentration

  3 months

Study Arms (3)

Vitamin D group

ACTIVE COMPARATOR

vitamin D supplementation - time to fracture healing

Dietary Supplement: Vitamin D supplementation

Vitamin D and K2 group

ACTIVE COMPARATOR

Vitamin D and K 2 supplementation - time of fracture healing

Dietary Supplement: Vitamin D and K2 supplementation

Placebo group

PLACEBO COMPARATOR

Placebo - time to fracture healing

Dietary Supplement: Placebo

Interventions

Vitamin D and K2 supplementation DIETARY_SUPPLEMENT

if supplementation of vitamin D and K2 changes the time to fracture healing

Vitamin D and K2 group

Vitamin D supplementation DIETARY_SUPPLEMENT

if supplementation of vitamin D alone changes the time to fracture healing

Vitamin D group

Placebo DIETARY_SUPPLEMENT

Placebo control group

Placebo group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \< 18 years
• Presence of low-energy fracture
• Vitamin D serum level \<30ng/ml

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Lomza State University of Applied Sciences: collaborator
• International Science & Health Foundation: collaborator
• American Medical Holdings Inc: collaborator

Study Sites (1)

Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok

Bialystok, 15-274, Poland

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Janusz Popko, MD, PhD

  Faculty of Health Sciences

  STUDY CHAIR

• Michał Karpinski, MD

  Department of Pediatric Orthopedics and Traumatology

  PRINCIPAL INVESTIGATOR

• Tomasz Guszczyn, MD, PhD

  Department of Pediatric Orthopedics and Traumatology

  STUDY CHAIR

• Sylwia Chojnowska, PhD

  Faculty of Health Sciences Lomza

  STUDY CHAIR

• Katarzyna Maresz, PhD

  International Science &amp;Health Foundation

  STUDY CHAIR

• Vladimir Badmaev

  American Medical Holdings Inc

  STUDY DIRECTOR

Central Study Contacts

Michał Karpiński, MD

CONTACT

692224714; gufkarp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo, same looking capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC),

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 12, 2019
• Study Start: July 1, 2019
• Primary Completion: December 24, 2022
• Study Completion: January 20, 2023
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)