Trial Outcomes & Findings for Evaluating the Effect of SOLIUS UV Light Source in Improving Vitamin D Status (NCT NCT04780776)
NCT ID: NCT04780776
Last Updated: 2024-10-22
Results Overview
This outcome measures the change in serum 25-hydroxyvitamin D \[25(OH)D\] concentrations in participants from Week 1 to the end of the intervention period Week 21.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Week 1, Week 21
Results posted on
2024-10-22
Participant Flow
Screened adults with vitamin D deficiency or insufficiency were selected for the study and randomized into the two study arms.
Participant milestones
| Measure |
UVB Treatment Arm
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Titration Week 1-5
STARTED
|
35
|
34
|
|
Titration Week 1-5
COMPLETED
|
33
|
26
|
|
Titration Week 1-5
NOT COMPLETED
|
2
|
8
|
|
Treatment Week 6-21
STARTED
|
33
|
26
|
|
Treatment Week 6-21
COMPLETED
|
29
|
22
|
|
Treatment Week 6-21
NOT COMPLETED
|
4
|
4
|
|
Follow up Week 22-25
STARTED
|
29
|
22
|
|
Follow up Week 22-25
COMPLETED
|
27
|
20
|
|
Follow up Week 22-25
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
UVB Treatment Arm
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Titration Week 1-5
Lost to Follow-up
|
2
|
8
|
|
Treatment Week 6-21
Lost to Follow-up
|
4
|
4
|
|
Follow up Week 22-25
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
UVB Treatment Arm
n=35 Participants
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
n=34 Participants
Participants receive blue/violet light exposure from the SOLIUS System.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.09 years
STANDARD_DEVIATION 10.78 • n=35 Participants
|
34.44 years
STANDARD_DEVIATION 11.40 • n=34 Participants
|
34.26 years
STANDARD_DEVIATION 11.01 • n=69 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=35 Participants
|
21 Participants
n=34 Participants
|
44 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=35 Participants
|
13 Participants
n=34 Participants
|
25 Participants
n=69 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=35 Participants
|
3 Participants
n=34 Participants
|
11 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=35 Participants
|
13 Participants
n=34 Participants
|
19 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Black- Cape Verde
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Black- Hispanic
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Black- Multirace
|
0 Participants
n=35 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=35 Participants
|
4 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Hispanic- White
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Hispanic- Multirace
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Multirace
|
0 Participants
n=35 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=35 Participants
|
12 Participants
n=34 Participants
|
25 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
34 participants
n=34 Participants
|
69 participants
n=69 Participants
|
|
Fitzpatrick Skin Type
Skin Type II/III
|
30 Participants
n=35 Participants
|
30 Participants
n=34 Participants
|
60 Participants
n=69 Participants
|
|
Fitzpatrick Skin Type
Skin Type IV/V
|
5 Participants
n=35 Participants
|
4 Participants
n=34 Participants
|
9 Participants
n=69 Participants
|
|
Screening 25(OH)D Levels
|
20.57 ng/mL
STANDARD_DEVIATION 5.30 • n=35 Participants
|
19.71 ng/mL
STANDARD_DEVIATION 5.16 • n=34 Participants
|
20.41 ng/mL
STANDARD_DEVIATION 5.21 • n=69 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 21This outcome measures the change in serum 25-hydroxyvitamin D \[25(OH)D\] concentrations in participants from Week 1 to the end of the intervention period Week 21.
Outcome measures
| Measure |
UVB Treatment Arm
n=27 Participants
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
n=20 Participants
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
|
10.14 ng/mL
Standard Deviation 7.5
|
-2.3 ng/mL
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Week 1Population: Only participants who completed the treatment are analyzed (27 in the treatment and 20 in the control arm).
The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Outcome measures
| Measure |
UVB Treatment Arm
n=27 Participants
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
n=20 Participants
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
Deficient
|
19 Participants
|
9 Participants
|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
Insufficient
|
6 Participants
|
10 Participants
|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
Sufficient
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 21Population: Only participants who completed the treatment are analyzed (27 in the treatment and 20 in the control arm).
The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Outcome measures
| Measure |
UVB Treatment Arm
n=27 Participants
Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
n=20 Participants
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
Deficient
|
3 Participants
|
16 Participants
|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
Insufficient
|
13 Participants
|
4 Participants
|
|
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
Sufficient
|
11 Participants
|
0 Participants
|
Adverse Events
UVB Treatment Arm
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Sham Comparator Arm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
UVB Treatment Arm
n=35 participants at risk
Participants receive ultra violet radiation (UVB) exposure from the SOLIUS System.
|
Sham Comparator Arm
n=34 participants at risk
Participants receive blue/violet light exposure from the SOLIUS System.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
34.3%
12/35 • 6 months
|
17.6%
6/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
22.9%
8/35 • 6 months
|
11.8%
4/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
11.4%
4/35 • 6 months
|
11.8%
4/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Darkening/tanning
|
11.4%
4/35 • 6 months
|
5.9%
2/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Tightness
|
11.4%
4/35 • 6 months
|
5.9%
2/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dryness
|
8.6%
3/35 • 6 months
|
0.00%
0/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Peeling
|
5.7%
2/35 • 6 months
|
0.00%
0/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Discomforts
|
2.9%
1/35 • 6 months
|
5.9%
2/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Sensitivity
|
2.9%
1/35 • 6 months
|
5.9%
2/34 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • 6 months
|
2.9%
1/34 • 6 months
|
Additional Information
Dr. Michael F. Holick
Boston University School of Medicine
Phone: (617) 358-6139
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place