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

NCT ID: NCT04780776

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2023-11-02

Brief Summary

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.

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.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

UVB treatment

Intervention Type: DEVICE

5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention

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.

Group Type: SHAM_COMPARATOR

Sham comparator

Intervention Type: DEVICE

5+16 weeks of visible light exposure

Interventions

UVB treatment

5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention

Intervention Type: DEVICE

Sham comparator

5+16 weeks of visible light exposure

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Holick, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

BU School of Medicine

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-40850

Identifier Type: -

Identifier Source: org_study_id