NCT04865432

Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D

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: A Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vitamin D Deficiency
• Vitamin D Insufficiency

Interventions

Type	Name	Description
DEVICE	UVB treatment	5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention

Timeline

• Start date: 2021-08-24
• Primary completion: 2021-12-12
• Completion: 2021-12-12
• First posted: 2021-04-29
• Last updated: 2022-12-23
• Results posted: 2022-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study