Trial Outcomes & Findings for Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury (NCT NCT03313076)
NCT ID: NCT03313076
Last Updated: 2025-03-17
Results Overview
A primary objective of this pilot study is to ensure safety of both treatments as well as combined. A qualitative review of treatment-related adverse events will be performed and a determination about the degree of relatedness of each adverse event with the intervention using CTCAE criteria will be made as CTCAE criteria assesses relatedness to therapy. Investigator reviewing the details of each adverse event rated the likelihood of relatedness to the study drug on a scale: (unrelated, unlikely, possible, probably, definitely).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 weeks following burn injury
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
2
|
Baseline Characteristics
Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
Baseline characteristics by cohort
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=6 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=6 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=5 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 9.39 • n=4 Participants
|
32.6 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Education
Completed High School
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Education
Post-high school education
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Education
College Graduate or beyond
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Income
<$40,000/year
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Income
$40,000-$59,999/year
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Income
$60,000-$99,999/year
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Income
>$100,000/year
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Income
Refused/Don't know
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Total Body Surface Area Burned
|
4.8 Percent total body surface area burned
STANDARD_DEVIATION 4.01 • n=5 Participants
|
7.9 Percent total body surface area burned
STANDARD_DEVIATION 6.4 • n=7 Participants
|
6.0 Percent total body surface area burned
STANDARD_DEVIATION 4.7 • n=5 Participants
|
5.3 Percent total body surface area burned
STANDARD_DEVIATION 3.9 • n=4 Participants
|
6.1 Percent total body surface area burned
STANDARD_DEVIATION 4.7 • n=21 Participants
|
|
Type of Thermal Burn
Flame
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Type of Thermal Burn
Contact
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Type of Thermal Burn
Scald
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Type of Thermal Burn
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Type of Thermal Burn
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeks following burn injuryPopulation: Enrolled participants who initiated study treatment
A primary objective of this pilot study is to ensure safety of both treatments as well as combined. A qualitative review of treatment-related adverse events will be performed and a determination about the degree of relatedness of each adverse event with the intervention using CTCAE criteria will be made as CTCAE criteria assesses relatedness to therapy. Investigator reviewing the details of each adverse event rated the likelihood of relatedness to the study drug on a scale: (unrelated, unlikely, possible, probably, definitely).
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=6 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=6 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=5 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Qualitative Review of Treatment-Related Adverse Events
Unrelated
|
3 adverse events
|
4 adverse events
|
2 adverse events
|
2 adverse events
|
|
Qualitative Review of Treatment-Related Adverse Events
Unlikely Related
|
1 adverse events
|
3 adverse events
|
2 adverse events
|
3 adverse events
|
|
Qualitative Review of Treatment-Related Adverse Events
Possibly Related
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
|
Qualitative Review of Treatment-Related Adverse Events
Probably Related
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Qualitative Review of Treatment-Related Adverse Events
Definitely Related
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: 6 weeks following burn injuryPopulation: After informed consent, initial survey completion, and randomization, 2 participants in the n-3 PUFA (O3FA) + Vitamin D3 dropped out of the study and were not included in these analyses.
The primary objective of this pilot study is to ensure that the investigators are able to make follow-up assessments on a majority of participants. The percent of participants who are compliant with follow-up will be determined 6 weeks following major thermal burn injury. Feasibility is defined as \>80% of enrolled participants at 6 weeks following Major Thermal Burn Injury (MThBI).
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=5 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=6 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=6 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=5 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Percent of Participants Who Are Compliant With Follow-up (Feasibility)
|
100 percentage of participants
|
50 percentage of participants
|
83.3 percentage of participants
|
80 percentage of participants
|
PRIMARY outcome
Timeframe: Over 1 year following MThBIPopulation: Given the 2x2 factorial design, comparisons were made to assess the differences between one treatment and placebo regardless of the other treatment. E.g. groups were combined to assess whether there was any difference between Vitamin D and placebo regardless of O3FA treatment.
Estimates of efficacy will be obtained via repeated measures analysis of pain severity over the 1 year following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as you can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 1 year following burn injury) will be entered into a linear mixed model, and overall effect estimates (beta coefficients) among groups will be determined. Final model was a piece-wise linear mixed model, with a cut-point at 6 weeks. Mixed models were adjusted for age, sex, race, initial pain severity. Every 1 unit change in beta coefficient represents a 1 unit change in pain severity on the 0-10 numeric rating scale.
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=13 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=11 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=13 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=11 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Baseline (Day 1)
|
7.19 score on a scale
Standard Deviation 1.15
|
7.57 score on a scale
Standard Deviation 1.83
|
7.01 score on a scale
Standard Deviation 1.72
|
7.65 score on a scale
Standard Deviation 1.14
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 1
|
5.7 score on a scale
Standard Deviation 2.21
|
5.50 score on a scale
Standard Deviation 2.21
|
5 score on a scale
Standard Deviation 2.65
|
6.09 score on a scale
Standard Deviation 2.21
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 2
|
4.5 score on a scale
Standard Deviation 2.99
|
3.8 score on a scale
Standard Deviation 3.01
|
3.22 score on a scale
Standard Deviation 2.33
|
4.91 score on a scale
Standard Deviation 3.27
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 3
|
2.0 score on a scale
Standard Deviation 2.45
|
2.8 score on a scale
Standard Deviation 2.49
|
1.9 score on a scale
Standard Deviation 1.97
|
2.90 score on a scale
Standard Deviation 2.85
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 4
|
1.73 score on a scale
Standard Deviation 2.20
|
2.33 score on a scale
Standard Deviation 1.94
|
1.6 score on a scale
Standard Deviation 1.78
|
2.4 score on a scale
Standard Deviation 2.32
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 5
|
1.22 score on a scale
Standard Deviation 1.48
|
1.43 score on a scale
Standard Deviation 1.27
|
1 score on a scale
Standard Deviation 1.15
|
1.56 score on a scale
Standard Deviation 1.51
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Week 6
|
1.6 score on a scale
Standard Deviation 1.58
|
1.57 score on a scale
Standard Deviation 2.94
|
0.75 score on a scale
Standard Deviation 1.04
|
2.33 score on a scale
Standard Deviation 2.65
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Month 3
|
0.67 score on a scale
Standard Deviation 1.15
|
0.33 score on a scale
Standard Deviation 0.58
|
0.25 score on a scale
Standard Deviation 0.5
|
1.0 score on a scale
Standard Deviation 1.41
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Month 6
|
1.14 score on a scale
Standard Deviation 1.46
|
0.33 score on a scale
Standard Deviation 0.82
|
0.67 score on a scale
Standard Deviation 1.03
|
0.86 score on a scale
Standard Deviation 1.46
|
|
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Month 12
|
1.2 score on a scale
Standard Deviation 2.17
|
0.5 score on a scale
Standard Deviation 1.0
|
0.6 score on a scale
Standard Deviation 0.89
|
1.25 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 weeks following burn injuryPopulation: The population included were participants who responded to the graft site pain severity question at the 6-week follow-up surveys. Treatment assignment of Omega-3 fatty acids or no Omega-3 fatty acids was considered independent of Vitamin D treatment. Treatment assignment of Vitamin D or no Vitamin D treatment was considered independent of Omega-3 fatty acid treatment.
Examines existence of gender-based treatment response differences in pain severity measured by a 0-10 numeric rating scale where 0 is no pain and 10 is the most severe pain. Higher scores reflect greater pain (poor outcome).
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=10 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=8 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=9 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Sex Differences in Treatment Response Based on Pain Scores
Female
|
2.00 units on a scale
Standard Deviation 1.00
|
1.00 units on a scale
Standard Deviation 1.42
|
2 units on a scale
Standard Deviation 0
|
1.33 units on a scale
Standard Deviation 1.52
|
|
Sex Differences in Treatment Response Based on Pain Scores
Male
|
1.43 units on a scale
Standard Deviation 1.81
|
1.80 units on a scale
Standard Deviation 3.49
|
0.33 units on a scale
Standard Deviation 0.81
|
2.83 units on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: 6 weeks following burn injuryPopulation: The population included were participants who responded to the graft site pain severity question at the 6-week follow-up surveys. Treatment assignment of Omega-3 fatty acids or no Omega-3 fatty acids was considered independent of Vitamin D treatment. Treatment assignment of Vitamin D or no Vitamin D treatment was considered independent of Omega-3 fatty acid treatment.
Assessment of mental health will be determined by the short form (SF)-12 mental component score. The short form SF-12 Health Survey is a 12-item participant completed questionnaire to measure general health. It includes a mental component score (MCS): ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good mental health.
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=10 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=8 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=9 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores
|
49.98 score on a scale
Standard Deviation 9.98
|
48.29 score on a scale
Standard Deviation 10.79
|
52.80 score on a scale
Standard Deviation 6.37
|
46.16 score on a scale
Standard Deviation 11.92
|
SECONDARY outcome
Timeframe: 6 weeks following burn injuryPopulation: The population included were participants who responded to the graft site pain severity question at the 6-week follow-up surveys. Treatment assignment of Omega-3 fatty acids or no Omega-3 fatty acids was considered independent of Vitamin D treatment. Treatment assignment of Vitamin D or no Vitamin D treatment was considered independent of Omega-3 fatty acid treatment.
Assessment of physical health will be determined by the SF-12 physical component score. The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health. It includes a physical component score (PCS): ranging from 0 to 100 points. Low values represent a poor physical health and high values represent a good physical health.
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=10 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=8 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=9 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores
|
40.84 score on a scale
Standard Deviation 6.25
|
40.12 score on a scale
Standard Deviation 6.40
|
40.83 score on a scale
Standard Deviation 3.85
|
40.29 score on a scale
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: 6 weeks following burn injuryPopulation: The population included were participants who responded to the graft site pain severity question at the 6-week follow-up surveys. Treatment assignment of Omega-3 fatty acids or no Omega-3 fatty acids was considered independent of Vitamin D treatment. Treatment assignment of Vitamin D or no Vitamin D treatment was considered independent of Omega-3 fatty acid treatment.
The degree to which pain interferes with important life function will be determined by the Brief Pain Inventory. This is a validated, self-reported scale that measures the severity of pain based on the average pain experienced and assesses impact of pain across 7 domains of life function (e.g., enjoyment of life, relationships, normal work). The total severity scores range from 0 (no interference) to 70 (maximum interference). Higher scores reflect greater pain interference.
Outcome measures
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=10 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=7 Participants
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=8 Participants
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=9 Participants
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Pain Interference by Treatment Group Measured by the Brief Pain Inventory
|
11.60 score on a scale
Standard Deviation 12.76
|
13.71 score on a scale
Standard Deviation 20.30
|
5.5 score on a scale
Standard Deviation 6.85
|
18.67 score on a scale
Standard Deviation 19.03
|
Adverse Events
n-3 PUFA (O3FA) + Vitamin D3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
n-3 PUFA (O3FA) Placebo + Vitamin D3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
n-3 PUFA (O3FA) + Vitamin D3
n=7 participants at risk
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3
n=6 participants at risk
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFAs (O3FA) + Vitamin D3 Placebo
n=6 participants at risk
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
|
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
n=5 participants at risk
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
20.0%
1/5 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Gastrointestinal disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Investigations
Medication administration error
|
14.3%
1/7 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Blood and lymphatic system disorders
Elevated PTT
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Oral Sore
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Nervous system disorders
Pain
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Transient Hypoxemia
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
20.0%
1/5 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
20.0%
1/5 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
20.0%
1/5 • Number of events 1 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
16.7%
1/6 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
0.00%
0/5 • After randomization through 6 weeks of active treatment
Participants responded via weekly surveys to assess adverse events
|
Additional Information
Matt Mauck, MD, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-5136
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place