Trial Outcomes & Findings for Association Between Vitamin D Receptor Polymorphism and Serum Vitamin D Levels in Children With Low-Energy Fractures (NCT NCT02805647)
NCT ID: NCT02805647
Last Updated: 2019-12-04
Results Overview
Serum concentrations of total vitamin D; VDR polymorphism test
Recruitment status
COMPLETED
Target enrollment
222 participants
Primary outcome timeframe
We measured Vitamin D status at the time of admission - at the time of fracture
Results posted on
2019-12-04
Participant Flow
Children with low energy fractures
without bone diseases such as OI
Participant milestones
| Measure |
Fracture/Study Group
The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
|
Control Group
The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
122
|
|
Overall Study
COMPLETED
|
100
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fracture/Study Group
n=100 Participants
The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
|
Control Group
n=122 Participants
The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=100 Participants
|
122 Participants
n=122 Participants
|
222 Participants
n=222 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=100 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=222 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=100 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=222 Participants
|
|
Age, Continuous
|
13 years
STANDARD_DEVIATION 2 • n=100 Participants
|
13 years
STANDARD_DEVIATION 2 • n=122 Participants
|
13 years
STANDARD_DEVIATION 2 • n=222 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=100 Participants
|
39 Participants
n=122 Participants
|
61 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=100 Participants
|
83 Participants
n=122 Participants
|
161 Participants
n=222 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Poland
|
100 participants
n=100 Participants
|
122 participants
n=122 Participants
|
222 participants
n=222 Participants
|
|
Total vitamin D [25(OH)D3 plus 25(OH)D2] serum concentrations were evaluated in every patient. Genot
|
13.81 ng/ml
STANDARD_DEVIATION 12 • n=100 Participants
|
17.49 ng/ml
STANDARD_DEVIATION 16 • n=122 Participants
|
15 ng/ml
STANDARD_DEVIATION 14 • n=222 Participants
|
PRIMARY outcome
Timeframe: We measured Vitamin D status at the time of admission - at the time of fracturePopulation: Children from Poland Podlasie region
Serum concentrations of total vitamin D; VDR polymorphism test
Outcome measures
| Measure |
Fracture/Study Group
n=100 Participants
The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
|
Control Group
n=122 Participants
The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
|
|---|---|---|
|
Vitamin D Status; VDR Status
|
13.81 ng/ml
Interval 8.0 to 18.0
|
17.49 ng/ml
Interval 11.0 to 23.0
|
Adverse Events
Fracture/Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
MichałKarpiński
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Phone: 692224714
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place