Trial Outcomes & Findings for Vitamin D Levels in Frail Elderly Patients With a Hip Fracture (NCT NCT01816711)
NCT ID: NCT01816711
Last Updated: 2020-12-23
Results Overview
Serum-25(OH)D was measured in a blood sample as an indicator of Vitamin D status
Recruitment status
COMPLETED
Target enrollment
447 participants
Primary outcome timeframe
Upon admission
Results posted on
2020-12-23
Participant Flow
Participant milestones
| Measure |
Hip Fracture, Frail Elderly, Non-supplemented
Cases: Frail elderly with a hip fracture who did not receive vitamin D supplementation
|
Hip Fracture, Frail Elderly, Supplemented
Frail elderly with a hip fracture who received vitamin D supplementation
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
83
|
|
Overall Study
COMPLETED
|
121
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D Levels in Frail Elderly Patients With a Hip Fracture
Baseline characteristics by cohort
| Measure |
Hip Fracture, Frail Elderly, Non-supplemented
n=121 Participants
Frail elderly with a hip fracture who did not receive vitamin D supplementation
|
Hip Fracture, Frail Elderly, Supplemented
n=83 Participants
Frail elderly with a hip fracture who received vitamin D supplementation
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87 years
n=5 Participants
|
83 years
n=7 Participants
|
87 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
121 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Senior housing
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Nursing home
|
77 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Upon admissionSerum-25(OH)D was measured in a blood sample as an indicator of Vitamin D status
Outcome measures
| Measure |
Hip Fracture, Frail Elderly, Non-supplemented
n=121 Participants
Frail elderly with a hip fracture who did not received vitamin D supplementation
|
Hip Fracture, Frail Elderly, Supplemented
n=83 Participants
Frail elderly with a hip fracture who received vitamin D supplementation
|
|---|---|---|
|
Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D)
Suboptimal level (<75nmol/l)
|
106 Participants
|
42 Participants
|
|
Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D)
Optimal level (>75nmol/l)
|
15 Participants
|
41 Participants
|
Adverse Events
Hip Fracture, Frail Elderly, Non-supplemented
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hip Fracture, Frail Elderly, Supplemented
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place