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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Vitamin D Insufficiency
• Intervention / Treatment: Device: UVB treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • General Clinical Research Unit (GCRU) BU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age at least 22 years old
2. Male or Female
3. Skin Type I-VI
4. Women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
5. Ability and Willingness to give informed consent and comply to protocol requirements
6. Serum total 25(OH)D < 30 ng/mL

Exclusion Criteria:

1. Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
2. Pregnant
3. History of underlying photosensitivity
4. Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
5. History of skin cancer
6. Plan to received significant sun exposure below the 33rd parallel during study
7. Used tanning or phototherapy devices within the last 30 days
8. Vitamin D supplement use of more than 600 IUs daily.
9. Systemic steroids use
10. H1 antihistamine use in the last 7 days
11. Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
12. Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: UVB treatment; 5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Michael Holick, PhD MD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D; Ultraviolet B radiation
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: H-41681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No