Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a feasibility interventional study seeking to determine the safety and efficacy of the Solius Photobiologic System in increasing the serum levels of 25(OH)D in a vitamin D deficient/insufficient adult population.
The investigators will conduct an interventional study to determine the changes in the changes in serum 25-hydroxyvitamin D levels between subjects who receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the Solius Photobiological System for 4 weeks. Subjects 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 4-week study where they will be exposed to their individualized titration evaluation. Approximately 14 adult participants will be enrolled for serum 25-hydroxyvitamin D screening. The investigators expect to enroll 10 vitamin D-deficient or insufficient subjects in this study. Serum 25-hydroxyvitamin D levels will be measured prior to the first titration (week 2), prior to the intervention (week 6) and after the end of the study, and and the changes in serum 25-hydroxyvitamin D levels will be analyzed. The investigators expect that the levels will increase from the baseline.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVB treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVB treatment | Device | 5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-hydroxyvitamin D | Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study) | Serum 25-hydroxyvitamin D at 4 weeks of intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Holick, PhD MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Unit (GCRU) BU School of Medicine | Boston | Massachusetts | 02118 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UVB Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum 25-hydroxyvitamin D | Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study) | Posted | Mean | Standard Deviation | ng/nl | Serum 25-hydroxyvitamin D at 4 weeks of intervention |
|
|
9 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UVB Treatment | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael F. Holick PhD, MD | Boston University Chobanian & Avedisian School of Medicine | 617-358-6139 | mfholick@bu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 | Nov 15, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum 25-hydroxyvitamin D level | Mean | Standard Deviation | ng/ml |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |