Fracture HealingNCT03871322
The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
A study testing Vitamin D and K2 supplementation and Vitamin D supplementation in people with Fracture Healing and Vitamin D3, run by Medical University of Bialystok at 1 site in Poland.
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 Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture Healing, Vitamin D3, Deficiency of Vitamin K2
- What is being tested?
- Vitamin D and K2 supplementation and Vitamin D supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2019to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age < 18 years
- Presence of low-energy fracture
- Vitamin D serum level <30ng/ml
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Bialystok, 15-274
Michal Karpinski, MD, 692224714 ext. +48, gufkarp@gmail.com
Janusz Popko, MD, PhD, 857450895 ext. +48, jpopko@umb.edu.pl
About this study
Official title: Rationale and Design of the Vitamin K2 and Vitamin D3 Intervention Trial in Children and Adolescents With the Low-energy Bone Fractures
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
Read the 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 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
- Conditions
- Fracture Healing, Vitamin D3, Deficiency of Vitamin K2
- Being tested
- Vitamin D and K2 supplementation, Vitamin D supplementation, Placebo
- Keywords
- vitamin D, vitamin K2, low-energy fractures, fracture healing, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and K2 supplementationDietary supplement
if supplementation of vitamin D and K2 changes the time to fracture healing
Vitamin D supplementationDietary supplement
if supplementation of vitamin D alone changes the time to fracture healing
PlaceboDietary supplement
Placebo control group
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Active comparator | vitamin D supplementation - time to fracture healing Receives: Dietary Supplement: Vitamin D supplementation |
| Vitamin D and K2 group | Active comparator | Vitamin D and K 2 supplementation - time of fracture healing Receives: Dietary Supplement: Vitamin D and K2 supplementation |
| Placebo group | Placebo comparator | Placebo - time to fracture healing Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
Vitamin D concentration changes
changes in vitamin D serum concentration
Measured: 3 months
Vitamin K2 concentration changes
changes in vitamin K2 serum concentration
Measured: 3 months
Changes in bone markers concentration
Changes in bone-specific alkaline phosphatase (BALP), N-terminal telopeptide (NTX)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jul 2019
- Primary completion24 Dec 2022 (estimated)
- Study completion20 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC),
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Lomza State University of Applied Sciences, International Science & Health Foundation, American Medical Holdings, Inc.
- Responsible party
- Sponsor
- Investigators
- Janusz Popko, MD, PhD, Study chair, Faculty of Health SciencesMichał Karpinski, MD, Principal investigator, Department of Pediatric Orthopedics and TraumatologyTomasz Guszczyn, MD, PhD, Study chair, Department of Pediatric Orthopedics and TraumatologySylwia Chojnowska, PhD, Study chair, Faculty of Health Sciences LomzaKatarzyna Maresz, PhD, Study chair, International Science &Health FoundationVladimir Badmaev, Study director, American Medical Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871322
- Sponsor's protocol ID
- MUBialystok1
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Design of the Vitamin K2 and Vitamin D3 Intervention Trial in Children and Adolescents With the Low-energy Bone Fractures
- ClinicalTrials.gov ID
- NCT03871322
- Acronym / sponsor ID
- MUBialystok1
- Conditions
- Fracture Healing, Vitamin D3, Deficiency of Vitamin K2
- Keywords
- vitamin D, vitamin K2, low-energy fractures, fracture healing, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Lomza State University of Applied Sciences, International Science & Health Foundation, American Medical Holdings, Inc.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 24 Dec 2022 (estimated)
- Study completion
- 20 Jan 2023 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC),
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Active comparator | Dietary Supplement: Vitamin D supplementationvitamin D supplementation - time to fracture healing |
| Vitamin D and K2 group | Active comparator | Dietary Supplement: Vitamin D and K2 supplementationVitamin D and K 2 supplementation - time of fracture healing |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo - time to fracture healing |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age < 18 years
- Presence of low-energy fracture
- Vitamin D serum level <30ng/ml
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D and K2 supplementationif supplementation of vitamin D and K2 changes the time to fracture healing | Dietary supplement | Vitamin D and K2 group |
| Vitamin D supplementationif supplementation of vitamin D alone changes the time to fracture healing | Dietary supplement | Vitamin D group |
| PlaceboPlacebo control group | Dietary supplement | Placebo group |
Primary outcome
time to bone union
Time frame: 3 months
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 secondary outcomes
Vitamin D concentration changes
Time frame: 3 months
Vitamin K2 concentration changes
Time frame: 3 months
Changes in bone markers concentration
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janusz Popko, MD, PhD study chair
Faculty of Health Sciences
Michał Karpinski, MD principal investigator
Department of Pediatric Orthopedics and Traumatology
Tomasz Guszczyn, MD, PhD study chair
Department of Pediatric Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and K2 supplementation and Vitamin D supplementation in people with Fracture Healing and Vitamin D3, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał Karpiński, MD (692224714 ext. 48, gufkarp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to bone union (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.