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Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status

Vitamin D Deficiency Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04780776
Study type Interventional
Source Boston University
Contact
Status Completed
Phase N/A
Start date February 23, 2022
Completion date October 20, 2023
View Details
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