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

Medical University of Bialystok

Status: Unknown

Conditions: Fracture Healing; Vitamin D3; Deficiency of Vitamin K2

Treatments: Dietary Supplement: Vitamin D supplementation; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D and K2 supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03871322

MUBialystok1

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Vitamin D group

Active Comparator group

Description:

vitamin D supplementation - time to fracture healing

Treatment:

Dietary Supplement: Vitamin D supplementation

Vitamin D and K2 group

Active Comparator group

Description:

Vitamin D and K 2 supplementation - time of fracture healing

Treatment:

Dietary Supplement: Vitamin D and K2 supplementation

Placebo group

Placebo Comparator group

Description:

Placebo - time to fracture healing

Treatment:

Dietary Supplement: Placebo