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

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D and K2 supplementation

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

DIETARY_SUPPLEMENT

Vitamin D supplementation

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

DIETARY_SUPPLEMENT

Placebo

Placebo control group

Sponsors & Collaborators

• Lomza State University of Applied Sciences

  collaborator UNKNOWN

• International Science & Health Foundation

  collaborator UNKNOWN

• American Medical Holdings Inc

  collaborator UNKNOWN

• Medical University of Bialystok

  lead OTHER

Principal Investigators

• Janusz Popko, MD, PhD · Faculty of Health Sciences

• Michał Karpinski, MD · Department of Pediatric Orthopedics and Traumatology

• Tomasz Guszczyn, MD, PhD · Department of Pediatric Orthopedics and Traumatology

• Sylwia Chojnowska, PhD · Faculty of Health Sciences Lomza

• Katarzyna Maresz, PhD · International Science &Health Foundation

• Vladimir Badmaev · American Medical Holdings Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2022-12-24

Completion

2023-01-20

Countries

• Poland

Study Locations