Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UVB treatment
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 4-week study 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

Recruiting Locations

General Clinical Research Unit (GCRU) BU School of Medicine
Boston, Massachusetts 02118
Contact:
Arash Shirvani, MD PhD
617-358-6142
hn@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Michael Holick, PhD MD
617-358-6139
mfholick@bu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.