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

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

The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types.

The investigators will conduct a 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 System for 16 weeks.

Study Overview

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

Detailed Description

Study enrollment

Approximately 100 healthy adults will be enrolled ages 22 or older; 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 System, and 40 adults for sham comparator arm.

Study procedure

The treatment group that will be exposed to the SOLIUS System will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the SOLIUS 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 to 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 after each UVB exposure for any adverse events, including erythema or any other skin reactions.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • BU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age at least 22 years old
2. Male or Female
3. Skin Type I-VI
4. Women of child bearing 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 at the screening

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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UVB treatment arm; The treatment group will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose.	Device: UVB treatment; 5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
Sham Comparator: Sham comparator arm; The sham comparator group will undergo the procedures as the treatment group with the exception that the SOLIUS System will only be turned on to emit visible radiation.	Device: Sham comparator; 5+16 weeks of visible light exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum 25-Hydroxyvitamin D [25(OH)D]	This outcome measures the change in serum 25-hydroxyvitamin D [25(OH)D] concentrations in participants from Week 1 to the end of the intervention period Week 21.	Week 1, Week 21
Distribution of Participants by Vitamin D Deficiency Categories at Week 1	The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.	Week 1
Distribution of Participants by Vitamin D Deficiency Categories at Week 21	The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.	Week 21

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Ultraviolet B radiation; SOLIUS System
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: H-40850

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.: Yes