Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status
Primary Purpose
Vitamin D Deficiency, Vitamin D Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UVB treatment
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Ultraviolet B radiation
Eligibility Criteria
Inclusion Criteria:
- Age at least 18 years' old
- Male or Female
- Skin Type I-VI
- Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
- Ability and Willingness to give informed consent and comply to protocol requirements
- Serum total 25(OH)D < 30 ng/mL at the screening
Exclusion Criteria:
- Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
- Pregnant
- History of underlying photosensitivity
- Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
- History of skin cancer
- Plan to received significant sun exposure below the 33rd parallel during study
- Used tanning or phototherapy devices within the last 30 days
- Vitamin D supplement use of more than 600 IUs daily.
- Systemic steroids use
- H1 antihistamine use in the last 7 days
- Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
- Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome
Sites / Locations
- BU School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
UVB treatment arm
Sham comparator arm
Arm Description
The treatment group 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 after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation.
The sham comparator group will undergo the procedures as the treatment group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation.
Outcomes
Primary Outcome Measures
Baseline serum 25-hydroxyvitamin D
Serum 25-hydroxyvitamin D at 4 weeks of intervention
Serum 25-hydroxyvitamin D at 8 weeks of intervention
Serum 25-hydroxyvitamin D at 12 weeks of intervention
Serum 25-hydroxyvitamin D at 16 weeks of intervention
Serum 25-hydroxyvitamin D at 1 week post-intervention
Serum 25-hydroxyvitamin D at 2 weeks post-intervention
Serum 25-hydroxyvitamin D at 3 weeks post-intervention
Serum 25-hydroxyvitamin D at 4 weeks post-intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04780776
Brief Title
Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status
Official Title
Evaluating the Effect of Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D in Vitamin D Deficient/ Insufficient Adults of Various Skin Types
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the safety and effectiveness of the Solius Photobiological System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types.
The invetigators will conduct an double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the Solius Photobiological System for 16 weeks.
Detailed Description
Study enrollment
Approximately 100 healthy adults will be enrolled ages >18; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficiency (serum 25-hydroxyvitamin D <30 ng/mL). Participants will be randomized 1:1 into two groups: 40 adults for treatment arm who will receive weekly exposures of ultraviolet radiation generated by the Solius Photobiological system, and 40 adults for sham comparator arm.
Study procedure
The treatment group that will be exposed to the Solius Photobiological System 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 after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation. At these visits, each subject assigned into both groups will be asked questions about consumption of vitamin D, sun exposure, and whether he/she has had any adverse changes in his/her health. Serum 25-hydroxyvitamin D levels will be measured at baseline and monthly, and the levels will be analyzed to compare between those who receive and who do not receive the UVB radiation intervention for baseline and during the 16-week treatment period. After the 16-week intervention, participants will be asked to return the study site weekly for measurement of serum 25-hydroxyvitamin D for 4 weeks. Serum 25(OH)D levels will be determined using the Liquid Chromatography with tandem mass spectrometry (LC/MS/MS) method. Safety will be monitored by interviewing the participants each UVB exposure for any adverse events, including erythema or any other skin reactions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Vitamin D Insufficiency
Keywords
Vitamin D, Ultraviolet B radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UVB treatment arm
Arm Type
Experimental
Arm Description
The treatment group 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 after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation.
Arm Title
Sham comparator arm
Arm Type
Sham Comparator
Arm Description
The sham comparator group will undergo the procedures as the treatment group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation.
Intervention Type
Device
Intervention Name(s)
UVB treatment
Intervention Description
5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
Intervention Type
Device
Intervention Name(s)
Sham comparator
Intervention Description
5+16 weeks of visible light exposure
Primary Outcome Measure Information:
Title
Baseline serum 25-hydroxyvitamin D
Time Frame
Baseline
Title
Serum 25-hydroxyvitamin D at 4 weeks of intervention
Time Frame
Week 4 of the intervention
Title
Serum 25-hydroxyvitamin D at 8 weeks of intervention
Time Frame
Week 8 of the intervention
Title
Serum 25-hydroxyvitamin D at 12 weeks of intervention
Time Frame
Week 12 of the intervention
Title
Serum 25-hydroxyvitamin D at 16 weeks of intervention
Time Frame
Week 16 of the intervention
Title
Serum 25-hydroxyvitamin D at 1 week post-intervention
Time Frame
Week 1 post-intervention
Title
Serum 25-hydroxyvitamin D at 2 weeks post-intervention
Time Frame
Week 2 post-intervention
Title
Serum 25-hydroxyvitamin D at 3 weeks post-intervention
Time Frame
Week 3 post-intervention
Title
Serum 25-hydroxyvitamin D at 4 weeks post-intervention
Time Frame
Week 4 post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age at least 18 years' old
Male or Female
Skin Type I-VI
Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
Ability and Willingness to give informed consent and comply to protocol requirements
Serum total 25(OH)D < 30 ng/mL at the screening
Exclusion Criteria:
Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
Pregnant
History of underlying photosensitivity
Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
History of skin cancer
Plan to received significant sun exposure below the 33rd parallel during study
Used tanning or phototherapy devices within the last 30 days
Vitamin D supplement use of more than 600 IUs daily.
Systemic steroids use
H1 antihistamine use in the last 7 days
Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael F Holick, PhD, MD
Phone
617-358-6139
Email
mfholick@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Engie Gobran, MS
Phone
617-638-4945
Email
engie@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Holick, MD PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BU School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Holick, MD PhD
Phone
617-358-6139
Email
mfholick@bu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status
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