Trial Outcomes & Findings for Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D (NCT NCT04865432)
NCT ID: NCT04865432
Last Updated: 2022-12-23
Results Overview
Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Serum 25-hydroxyvitamin D at 4 weeks of intervention
Results posted on
2022-12-23
Participant Flow
Participant milestones
| Measure |
UVB Treatment
Participants will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System Ultraviolet B (UVB) using the device titration system for the first 5 weeks. Once determined, participants will participate in a 4-week intervention where they will be exposed to their individualized titration evaluation.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D
Baseline characteristics by cohort
| Measure |
UVB Treatment
n=10 Participants
Participants will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System UVB using the device titration system for the first 5 weeks. Once determined, participants will participate in a 4-week intervention where they will be exposed to their individualized titration evaluation.
|
|---|---|
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Age, Continuous
|
28.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Serum 25-hydroxyvitamin D level
|
24.0 ng/ml
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Serum 25-hydroxyvitamin D at 4 weeks of interventionSerum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study)
Outcome measures
| Measure |
UVB Treatment
n=10 Participants
Participants will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System UVB using the device titration system for the first 5 weeks. Once determined, participants will participate in a 4-week intervention where they will be exposed to their individualized titration evaluation.
|
|---|---|
|
Serum 25-hydroxyvitamin D
|
25.4 ng/nl
Standard Deviation 7.3
|
Adverse Events
UVB Treatment
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
Michael F. Holick PhD, MD
Boston University Chobanian & Avedisian School of Medicine
Phone: 617-358-6139
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place