Trial Outcomes & Findings for Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing (NCT NCT02786498)
NCT ID: NCT02786498
Last Updated: 2022-03-31
Results Overview
FIX-IT is a standardized measure of weight-bearing and pain in patients with lower extremity fractures, specifically tibia and femur fractures. The FIX-IT score ranges from 0 to 12 points in 2 domains: the ability to bear weight (maximum 6 points) and pain at the fracture site (maximum 6 points) The ability to bear weight is assessed through the single-leg stand and ambulation procedures. Pain is assessed through palpation and stress procedures. The scores in both domains, which are weighted equally, are summed to obtain the final total score; the maximum score of 12 indicates the highest level of function.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
3 months post-injury
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
High Loading Dose
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
24
|
27
|
|
Overall Study
COMPLETED
|
25
|
24
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Baseline characteristics by cohort
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
102 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 8.1 • n=39 Participants
|
28.8 years
STANDARD_DEVIATION 7.3 • n=41 Participants
|
31.1 years
STANDARD_DEVIATION 9.8 • n=35 Participants
|
31.3 years
STANDARD_DEVIATION 7.9 • n=31 Participants
|
29.65 years
STANDARD_DEVIATION 8.28 • n=146 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
70 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
97 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
47 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
48 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=39 Participants
|
24 participants
n=41 Participants
|
24 participants
n=35 Participants
|
27 participants
n=31 Participants
|
102 participants
n=146 Participants
|
|
Smoking status
Current Smoker
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
37 Participants
n=146 Participants
|
|
Smoking status
Previous Smoker
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
|
Smoking status
Non-Smoker
|
16 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
59 Participants
n=146 Participants
|
|
Fractured bone (Tibia)
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
41 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 32.A
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 32.B
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
16 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 32.C
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 42.A
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 42.B
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
|
Association for the Study of Internal fixation /Orthopaedic Trauma AssociationClassification (AO/OTA
AO/OTA Class 42.C
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Vitamin D3 deficient (25(OH)D Serum Levels ,20 ng/mL)
|
16 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
56 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 3 months post-injuryFIX-IT is a standardized measure of weight-bearing and pain in patients with lower extremity fractures, specifically tibia and femur fractures. The FIX-IT score ranges from 0 to 12 points in 2 domains: the ability to bear weight (maximum 6 points) and pain at the fracture site (maximum 6 points) The ability to bear weight is assessed through the single-leg stand and ambulation procedures. Pain is assessed through palpation and stress procedures. The scores in both domains, which are weighted equally, are summed to obtain the final total score; the maximum score of 12 indicates the highest level of function.
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT)
|
10.1 scores on a scale
Standard Deviation 2.5
|
9.7 scores on a scale
Standard Deviation 2.8
|
9.3 scores on a scale
Standard Deviation 3.3
|
9.0 scores on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 3 months post-injuryRadiographic fracture healing was measured using the Radiographic Union Score for Tibial fractures (RUST), which assesses the presence of bridging callus or a persistent fracture line on each of four cortices. This method evaluates two orthogonal radiographic views; each cortex is attributed points ranging from 1 to 3. A fracture in the immediate postoperative period will receive the minimum score, 4, (1 point for each of the four cortices) and a fully consolidated or healed fracture will be assigned the maximum score, 12 (3 points on each of the four cortices).
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST)
|
11.0 Score on a scale 4-12
Standard Deviation 2.8
|
11.3 Score on a scale 4-12
Standard Deviation 2.9
|
11.0 Score on a scale 4-12
Standard Deviation 3.0
|
10.4 Score on a scale 4-12
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 3 months post-injuryThe BTM C-terminal telopeptide of type I collagen (CTX). CTX is a marker of bone resorption. Clinically important changes in the CTX markers are unknown; however, in a previous study of tibia fracture healing, Veitch et al observed concentrations of both bone turnover markers approximately 100% greater than baseline values.43 Given the large changes observed in these bone turnover markers, the same criteria will be applied for identifying a potentially clinically beneficial regimen and remain powered to detect a mean difference of 20% (SD 30%).
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX)
|
0.59 ng/mL
Standard Deviation 0.75
|
0.79 ng/mL
Standard Deviation 0.93
|
0.67 ng/mL
Standard Deviation 0.64
|
0.78 ng/mL
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: 3 months post-injuryP1NP is a bone-formation marker and prior research has found that it is highest at 12 weeks after fractures of the tibial shaft and proximal femur.
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP)
|
160.9 ng/mL
Standard Deviation 140.1
|
187.8 ng/mL
Standard Deviation 129.3
|
166.7 ng/mL
Standard Deviation 115.8
|
140.7 ng/mL
Standard Deviation 124.7
|
SECONDARY outcome
Timeframe: Up to 3 months post-injuryPopulation: Serum 25(OH)D Concentration by Treatment Group
Correlations will be assessed between participants' 25(OH)D levels at enrolment, changes in 25(OH)D levels from enrolment to 3 months, and 25(OH)D levels at 3 months and fracture healing
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Serum Level of 25(OH)D
Baseline
|
18.8 ng/mL
Standard Deviation 7.8
|
20.7 ng/mL
Standard Deviation 9.6
|
19.7 ng/mL
Standard Deviation 7.9
|
17.3 ng/mL
Standard Deviation 7.5
|
|
Serum Level of 25(OH)D
Week 6
|
39.3 ng/mL
Standard Deviation 17.8
|
38.4 ng/mL
Standard Deviation 18.6
|
35.5 ng/mL
Standard Deviation 22.5
|
26.1 ng/mL
Standard Deviation 15.4
|
|
Serum Level of 25(OH)D
Month 3
|
39.9 ng/mL
Standard Deviation 17.9
|
28.2 ng/mL
Standard Deviation 20.7
|
38.1 ng/mL
Standard Deviation 19.8
|
23.1 ng/mL
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Up to 3 months post-injuryWill measure adherence with vitamin D supplementation based on participants self report at the 6 week and 3 month visits.
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Number of Participants With Adherence With Vitamin D Supplementation
6 Weeks
|
19 Participants
|
20 Participants
|
18 Participants
|
22 Participants
|
|
Number of Participants With Adherence With Vitamin D Supplementation
3 Months
|
21 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-injuryA count of the participants who experienced adverse events will measure participant safety
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
9 Participants
|
10 Participants
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 3 months post-injuryWill measure participant safety
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Serum Levels of Calcium
baseline
|
9.1 mg/dL
Standard Deviation 0.6
|
8.8 mg/dL
Standard Deviation 0.7
|
8.3 mg/dL
Standard Deviation 1.8
|
9.0 mg/dL
Standard Deviation 0.6
|
|
Serum Levels of Calcium
Week 6
|
9.6 mg/dL
Standard Deviation 0.3
|
9.6 mg/dL
Standard Deviation 0.3
|
9.6 mg/dL
Standard Deviation 0.4
|
9.6 mg/dL
Standard Deviation 0.5
|
|
Serum Levels of Calcium
Month 3
|
9.5 mg/dL
Standard Deviation 0.3
|
9.6 mg/dL
Standard Deviation 0.5
|
9.7 mg/dL
Standard Deviation 0.4
|
9.6 mg/dL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Up to 3 months post-injuryHelps the body to maintain stable levels of calcium in the blood
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Serum Levels of Parathyroid Hormone
Baseline
|
69.6 pg/mL
Standard Deviation 39.0
|
64.7 pg/mL
Standard Deviation 37.2
|
67.8 pg/mL
Standard Deviation 35.1
|
60.3 pg/mL
Standard Deviation 31.1
|
|
Serum Levels of Parathyroid Hormone
Week 6
|
41.9 pg/mL
Standard Deviation 47.7
|
28.8 pg/mL
Standard Deviation 32.2
|
68.0 pg/mL
Standard Deviation 63.2
|
43.6 pg/mL
Standard Deviation 47.7
|
|
Serum Levels of Parathyroid Hormone
Month 3
|
42.4 pg/mL
Standard Deviation 39.6
|
71.0 pg/mL
Standard Deviation 68.0
|
63.1 pg/mL
Standard Deviation 48.1
|
74.6 pg/mL
Standard Deviation 60.6
|
SECONDARY outcome
Timeframe: Up to 3 months post-injuryWill measure participants adherence to the blood measures of the protocol.
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Count of Participants Who Completed Blood Measures
baseline
|
26 Participants
|
24 Participants
|
24 Participants
|
26 Participants
|
|
Count of Participants Who Completed Blood Measures
Week 6
|
21 Participants
|
20 Participants
|
15 Participants
|
22 Participants
|
|
Count of Participants Who Completed Blood Measures
Month 3
|
19 Participants
|
11 Participants
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsCount of participants who completed radiographic imaging measures to determine participant protocol adherence and assists with identifying healing status
Outcome measures
| Measure |
High Loading Dose
n=27 Participants
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 Participants
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 Participants
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Count of Participants Who Completed Radiographic Imaging Measures
Baseline
|
27 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
|
Count of Participants Who Completed Radiographic Imaging Measures
Week 6
|
24 Participants
|
22 Participants
|
17 Participants
|
19 Participants
|
|
Count of Participants Who Completed Radiographic Imaging Measures
Month 3
|
21 Participants
|
17 Participants
|
20 Participants
|
16 Participants
|
|
Count of Participants Who Completed Radiographic Imaging Measures
Month 6
|
16 Participants
|
11 Participants
|
13 Participants
|
13 Participants
|
|
Count of Participants Who Completed Radiographic Imaging Measures
Month 9
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Count of Participants Who Completed Radiographic Imaging Measures
Month 12
|
6 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
High Loading Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
High Daily Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Low Daily Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Loading Dose
n=27 participants at risk
150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Vitamin D3
Placebo
|
High Daily Dose
n=24 participants at risk
Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Low Daily Dose
n=24 participants at risk
Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.
Vitamin D3
Placebo
|
Control Group
n=27 participants at risk
Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.
Placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture Healing Complication
|
18.5%
5/27 • Number of events 5 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
16.7%
4/24 • Number of events 4 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
20.8%
5/24 • Number of events 5 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
22.2%
6/27 • Number of events 6 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Musculoskeletal and connective tissue disorders
Non-study Fracture
|
3.7%
1/27 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
7.4%
2/27 • Number of events 2 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Vascular disorders
Vascular
|
7.4%
2/27 • Number of events 2 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
12.5%
3/24 • Number of events 3 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
11.1%
3/27 • Number of events 3 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
3.7%
1/27 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
General disorders
Accident/Fall
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
3.7%
1/27 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Respiratory, thoracic and mediastinal disorders
Recurrent Pneumothorax
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Musculoskeletal and connective tissue disorders
Retained Foreign Object
|
3.7%
1/27 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
3.7%
1/27 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Infections and infestations
Cellulitus
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
4.2%
1/24 • Number of events 1 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Blood and lymphatic system disorders
Sickle Cell Crisis
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/24 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
12.5%
3/24 • Number of events 3 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
0.00%
0/27 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
|
Musculoskeletal and connective tissue disorders
Re-operations for fracture healing complications
|
14.8%
4/27 • Number of events 4 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
16.7%
4/24 • Number of events 4 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
8.3%
2/24 • Number of events 2 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
25.9%
7/27 • Number of events 7 • 12 months after initial injury
An Adverse Event (AE) is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious.
|
Additional Information
Dr Gerard Slobogean
University of Maryland Baltimore, School of Medicine, Department of Orthopaedics
Phone: 410-28-6280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place